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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03617133
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT03617133
Ethics application status
Date submitted
13/07/2018
Date registered
6/08/2018
Date last updated
17/03/2022
Titles & IDs
Public title
Image Guided IMRT, Radiochemotherapy and MRI-based IGABT in Locally Advanced Cervical Cancer
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Scientific title
Image Guided Intensity Modulated External Beam Radiochemotherapy and MRI Based Adaptive BRAchytherapy in Locally Advanced CErvical Cancer
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Secondary ID [1]
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EMBRACE 2
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Universal Trial Number (UTN)
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Trial acronym
EMBRACEII
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Uterine Cervical Neoplasms
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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Cervical (cervix)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Increased use of IC/IS technique in BT
Treatment: Other - Reduction of vaginal source loading
Treatment: Other - Systematic utilisation of IMRT
Treatment: Other - Utilisation of daily IGRT (set-up according to bony structures)
Treatment: Other - EBRT target concept related to the primary tumor (CTV-T) and internal motion; concepts for OAR contouring
Treatment: Other - EBRT dose prescription and reporting
Treatment: Other - Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence
Treatment: Drugs - Systemic application of simultaneous chemotherapy
Other interventions - Reduction of overall treatment time
Other: Standard arm - General and specific aims of EMBRACEII as well as the multiple quantitative hypotheses are based on technical data, dose volume parameters and clinical results of the prospective observational study EMBRACEI (NCT00920920, 3 year data 2015) and the retrospective RetroEMBRACE (3/5 year data 2015). The performance of EMBRACE II interventions and clinical outcome in terms of disease- (local, nodal, systemic control, OS, CSS) and morbidity-outcome (various organs and endpoints) is thus based on recent clinical evidence with radiochemotherapy and image guided adaptive brachytherapy. The expected effect of EMBRACE II interventions on clinical outcome is estimated from comparative analyses of interventions in subgroups of Retro-/EMBRACE (partly published). Based on the Retro-/EMBRACE benchmark, the estimated outcome including a confidence interval is quantified for each clinical endpoint in the overall cohort as well as different subgroups for an overall expected patient number of 1000.
Treatment: Other: Increased use of IC/IS technique in BT
In EMBRACE II, the improved therapeutic window (through increased application of IC/IS) will be exploited for tumour dose-(de-)escalation and/or OAR dose de-escalation. In tumours with large residual CTVHR volumes at time of brachytherapy, dose-escalation has the potential to improve local control significantly. In limited size CTVHR volumes dose-de-escalation will be performed since dose de-escalation has minor impact on local control while it has potential to reduce morbidity. The strategy of EMBRACEII is to aim for an application of the IC/IS technique in at least 20% of the patients in each institution. The threshold of 20% is relevant for a classical stage distribution of ~20% IB, ~50% IIB, ~20% IIIB and ~10% others. If a given patient population includes significantly higher proportions of limited or extensive disease, the threshold of 20% IC/IS applications must be adapted.
Treatment: Other: Reduction of vaginal source loading
A multicenter investigation in 50 EMBRACE patients from 3 institutions (Mohamed SM. et al, in submission 2015) shows that reduced loading in ring/ovoids and increased loading in tandem (and needles when available) can be applied without compromising CTVHR and GTVres dose. Decrease of relative vaginal loading from a mean of 50% to 33% had potential to reduce ICRU recto-vaginal dose by a mean of 4±4Gy, and furthermore, bladder and rectum doses could be reduced by 2-3Gy with the same re-arrangement of loading. Similar evidence is available from a study on simulation of different intracavitary standard loading patterns in EMBRACE patients, where it was shown that limited size tumours could often be covered by tandem loading alone (Nkiwane KS. et al. 2013).
Treatment: Other: Systematic utilisation of IMRT
Many institutions deliver 3D conformal radiotherapy (3D CRT) based on a four-field box technique although IMRT has been available for a number of years. The practice in EMBRACEI has been utilisation of IMRT and 3D CRT in 27% and 73% of the patients, respectively. However, EMBRACE morbidity data as well as data published by Mundt et al (Mundt AJ. et al. 2003) indicate that IMRT significantly reduces the incidence of bowel morbidity, and therefore IMRT is considered as instrumental for reducing the incidence of bowel morbidity and with a potential also to be beneficial for urinary morbidity.
Treatment: Other: Utilisation of daily IGRT (set-up according to bony structures)
PTV margins of 10 mm to the elective lymph node target are currently applied in many institutions. This margin is related to set-up uncertainties with patient positioning performed based on skin marks. However, currently, most institutions have in-room imaging available which makes it possible to perform daily imaging and couch correction according to fusion on bony anatomy. With daily imaging, bony image fusion, and couch correction, a margin reduction from 10mm to 5mm can be performed without compromising target coverage (Laursen LV. et al. 2012). The 5mm margin reduction has potential to decrease the volume irradiated to 43Gy by approximately 500cm, which is expected to decrease bowel morbidity by ~50%.
Treatment: Other: EBRT target concept related to the primary tumor (CTV-T) and internal motion; concepts for OAR contouring
New target concepts are introduced for EBRT related to primary tumor: initial CTV-T, initial CTV-HR, initial CTV-LR and ITV-LR. Use of this novel contouring approach in conjunction with available MRI allows to target safely the visible tumor (CTV-T) and the high risk region (CTV-HRintitial) while consenting for dose to a low risk region (CTV-LRinitial). Anatomical changes due to organ filling variation and cervix/uterus position are considered. ITV-LR is outlined using planning scan and MR images in patients with MRI in treating position while a fixed margin is added to the CTV-LR initial in patients with only diagnostic MRI. New concepts are introduced for OAR contouring. Bowel loops are outlined in one volume restricted to the outer contour, including the mesenterium, for better approximation of the bowel volume and dose constraints. Rectum/sigmoid structures are contoured distinctly. Vaginal lower border is 2,5cm from the caudal extend of the tumor (2cm ITV-LR initial + 0,5cm PTV).
Treatment: Other: EBRT dose prescription and reporting
There is currently a significant variation with regard to EBRT dose and fractionation in the EMBRACE study with doses ranging from 45Gy to 50Gy and being delivered in 25-30 fractions. Furthermore, there is a wide variety of lymph node boosting strategies. In EMBRACEII, the EBRT dose and fractionation to the elective lymph node CTV and initial CTV-T is fixed at 45Gy in 25 fractions, and lymph node boosting must be performed as a simultaneous integrated boost. The dose de-escalation from 50Gy to 45Gy has potential to reduce morbidity. A system of reporting dose to targets and OARs is introduced in terms of dose volume parameters and a system of point dose reporting for the vagina.
Treatment: Other: Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence
EMBRACEII applies a risk adapted target concept for nodal CTV. This target concept is based on pattern of nodal recurrence analysis which shows 50% of recurrences beyond the classical L5/S1 cranial pelvic field border. A target volume "Large Pelvis" is defined for intermediate risk patients and includes internal, external, common iliac, obturator and presacral nodes. For high risk patients, defined as common iliac or >2 nodes involved, the para-aortic region is included. For low risk patients, defined as stage IA/IB1/IIA1, N0, small cell carcinoma (SCC), no uterine invasion, "Small Pelvis" is defined which is "Large Pelvis" without common iliac nodes. Intermediate risk is defined as not high and not low risk.
Treatment: Drugs: Systemic application of simultaneous chemotherapy
According to international standard and evidence, simultaneous chemotherapy (CHT) (min. 5x40 mg/m2 cis Platinum) was prescribed in the EMBRACE protocol for all patients, who qualify for its administration. Certain rules were given for adaption according to international guidelines. 90-95% of EMBRACE patients received simultaneous CHT. Most of the EMBRACE cohort is consecutive patients representing the cervix cancer patient population in the respective centers. About 70% of patients received =5 cycles, while 30% received 0-4 cycles. CHT has impact on systemic control, which is pronounced in high risk patients (node positive and/or stage III/IV) with a 20% difference in systemic recurrence. A center effect has been found in the ability to administer chemotherapy with 15-85% of the patients receiving =5 cycles of CHT. To reach optimal outcome, particularly in the high risk group, the EMBRACEII protocol also focusses on appropriate administration of CHT following international guidelines.
Other interventions: Reduction of overall treatment time
Several studies indicate that maintaining an overall treatment time (OTT) of <=50 days is important for local control. RetroEMBRACE data confirms that OTT remains of importance in the realm of IGABT. As there is significant variation of OTT across patients and institutions in retroEMBRACE, the EMBRACEII study aims to reduce the OTT so that the majority of patients (>80%) will adhere to the <=50 day threshold. The measures to reduce OTT in EMBRACE is to systematically apply 25 fractions of EBRT including lymph node boost, and furthermore to carefully plan the BT schedule, so that brachytherapy is delivered towards the end of EBRT and/or directly after EBRT.
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Intervention code [1]
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Treatment: Other
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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local control
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Assessment method [1]
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Timepoint [1]
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5 years
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Primary outcome [2]
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nodal control
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Assessment method [2]
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Timepoint [2]
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5 years
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Primary outcome [3]
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systemic control
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Assessment method [3]
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Timepoint [3]
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5 years
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Primary outcome [4]
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overall survival
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Assessment method [4]
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Timepoint [4]
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5 years
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Primary outcome [5]
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overall morbidity
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Assessment method [5]
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Timepoint [5]
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5 years
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Primary outcome [6]
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health-related quality of life: physical functioning
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Assessment method [6]
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European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.
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Timepoint [6]
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5 years
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Primary outcome [7]
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health-related quality of life: role functioning
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Assessment method [7]
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European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.
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Timepoint [7]
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5 years
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Primary outcome [8]
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health-related quality of life: social functioning
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Assessment method [8]
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European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire. Scores ranging from 0 to 100, higher scores indicating better functioning.
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Timepoint [8]
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5 years
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Secondary outcome [1]
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cancer specific survival
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Assessment method [1]
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5 years
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Secondary outcome [2]
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disease specific survival
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Assessment method [2]
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5 years
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Eligibility
Key inclusion criteria
- Cancer of the uterine cervix considered suitable for curative treatment with
definitive radio-(chemo)therapy including MRI guided BT
- Positive biopsy showing squamous-cell carcinoma, adenocarcinoma or adeno-squamous cell
carcinoma of the uterine cervix.
- Staging according to FIGO and TNM guidelines
- MRI of pelvis at diagnosis is performed
- MRI, CT or PET-CT of the retroperitoneal space and abdomen at diagnosis is performed
- MRI with the applicator in place at the time of (first) BT will be performed
- Para-aortic metastatic nodes below L1-L2 are allowed
- Patient informed consent
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Minimum age
18
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Maximum age
99
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Other primary malignancies except carcinoma in situ of the cervix and basal cell
carcinoma of the skin
- Small cell neuroendocrine cancer, melanoma and other rare cancers in the cervix
- Metastatic disease above and beyond the retroperitoneal para-aortic L1-L2 interspace
- Previous pelvic or abdominal radiotherapy
- Previous total or partial hysterectomy
- Combination of preoperative radiotherapy with surgery
- Patients receiving BT only
- Patients receiving EBRT only
- Patients receiving neo-adjuvant chemotherapy or other forms of antineoplastic
treatment apart from weekly concomitant cisplatin (40 mg/2). However, adjuvant
chemotherapy in the form of 4 courses of 3 weekly Carboplatin (AUC 5) and Paclitaxel
(155 mg/m2) is allowed according to departmental policy.
- Contra indications to MRI
- Contra indications to BT
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2031
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Actual
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Sample size
Target
1000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Vienna
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Funding & Sponsors
Primary sponsor type
Other
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Name
Medical University of Vienna
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Address
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Other
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Universitaire Ziekenhuizen KU Leuven
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Aarhus University Hospital
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Rigshospitalet, Denmark
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Odense University Hospital
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North Estonia Medical Centre
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Institut Bergonié
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Gustave Roussy, Cancer Campus, Grand Paris
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University Hospital Heidelberg
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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Oslo University Hospital
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Institute of Oncology Ljubljana
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Complejo Hospitalario de Navarra
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Hospital Clinic of Barcelona
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Skane University Hospital
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Region Örebro County
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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Radiotherapiegroep
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Leiden University Medical Center
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Maastro Clinic, The Netherlands
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UMC Utrecht
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The Netherlands Cancer Institute
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Radboud University Medical Center
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Catharina Ziekenhuis Eindhoven
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Erasmus Medical Center
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Cambridge University Hospitals NHS Foundation Trust
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The Leeds Teaching Hospitals NHS Trust
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The Christie NHS Foundation Trust
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University Hospitals Coventry and Warwickshire NHS Trust
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University Hospitals Bristol and Weston NHS Foundation Trust
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Royal Marsden NHS Foundation Trust
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Cross Cancer Institute
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McGill University
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Princess Margaret Hospital, Canada
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Tom Baker Cancer Centre
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Loyola University Chicago
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M.D. Anderson Cancer Center
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University of Pittsburgh
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Pamela Youde Nethersole Eastern Hospital
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Tuen Mun Hospital
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Postgraduate Institute of Medical Education and Research, Chandigarh
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Tata Memorial Centre
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Chulalongkorn University
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Siriraj Hospital
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Liverpool Hospital, Sydney
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Maisonneuve-Rosemont Hospital
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National Cancer Institute, Slovakia
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Institut Català d'Oncologia
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Ludwig-Maximilians - University of Munich
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Mount Vernon Cancer Centre
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Other
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St Thomas' Hospital, London
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Ethics approval
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Summary
Brief summary
The research group on adaptive image-guided radiotherapy for locally advanced cervical
carcinoma completed the protocol for the EMBRACE II study in October 2018. This study will be
carried out in the next few years at the University Clinic for Radiotherapy at the Medical
University of Vienna and other international partner institutes. EMBRACE II builds on the
findings of the current EMBRACE study. These are already implemented in everyday clinical
practice in order to further improve the accuracy of the entire therapy of cervical
carcinomas, using state-of-the-art techniques of tele- and brachytherapy. The aim of the
EMBRACE II study is to maintain and enhance the excellent local tumor control as well as the
nodal and systemic control for all tumor stages while minimizing the adverse reaction rates
for all affected organs (rectum, sigmoid, urinary bladder, and vagina) to increase the
quality of life of patients with cervical carcinomas.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03617133
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Richard Pötter, MD
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Medical University of Vienna
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Richard Pötter, MD
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0043140400
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03617133
Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW
Recruitment hospital [1]
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Liverpool Hospital
Recruitment hospital [2]
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Campbelltown Hospital
Recruitment postcode(s) [1]
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2170
Recruitment postcode(s) [2]
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2560
Funding & Sponsors
Primary sponsor
Hospital
Primary sponsor name
South Western Sydney Local Health District
Primary sponsor address
South Western Sydney Local Health District (SWSLHD)
Locked Bag 7103 Liverpool BC NSW 1871
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
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South Western Sydney Local Health District Human Research Ethics Committee
Address [1]
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South Western Sydney Local Health District (SWSLHD) Locked Bag 7103 Liverpool BC NSW 1871
Country [1]
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Australia
Date submitted for ethics approval [1]
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27/05/2019
Approval date [1]
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25/06/2019
Ethics approval number [1]
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2019/ETH00443
Public notes
Contacts
Principal investigator
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Dr
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Karen Lim
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South Western Sydney Local Health District (SWSLHD) Locked Bag 7103 Liverpool BC NSW 1871
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Australia
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+61 2 8738 9805
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+61 2 8738 9819
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[email protected]
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Ms
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Tess Afinidad
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South Western Sydney Local Health District (SWSLHD) Locked Bag 7103 Liverpool BC NSW 1871
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Australia
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+61 2 8738 9146
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+61 2 8738 9205
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[email protected]
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Contact person for scientific queries
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Dr
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Karen Lim
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South Western Sydney Local Health District (SWSLHD) Locked Bag 7103 Liverpool BC NSW 1871
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Australia
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+61 2 8738 9805
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+61 2 8738 9819
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[email protected]
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