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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/NCT04031677
Additional trial details provided through ANZCTR are available at the end of this record.
Registration number
NCT04031677
Ethics application status
Date submitted
22/07/2019
Date registered
24/07/2019
Date last updated
3/04/2024
Titles & IDs
Public title
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
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Scientific title
A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)
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Secondary ID [1]
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EA7211
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Secondary ID [2]
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EORTC 1809-STBSG
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Universal Trial Number (UTN)
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Trial acronym
STRASS2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Retroperitoneal Sarcoma
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Liposarcoma
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Leiomyosarcoma
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Condition category
Condition code
Cancer
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Sarcoma (also see 'Bone') - soft tissue
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Cancer
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Bone
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Surgery
Treatment: Drugs - Preoperative chemotherapy
Other: Standard arm - Surgery alone
Experimental: Experimental arm - Preoperative chemotherapy and surgery
Treatment: Surgery: Surgery
Large en-bloc curative-intent surgery
Treatment: Drugs: Preoperative chemotherapy
- High grade LPS: ADM 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m2 Q3 weeks
Note: the recommended dose of Ifosfamide can be modified according to national/institutional guidelines, given that the minimum threshold must be 7.5 g/m2 per cycle.
- LMS: ADM 75 mg/m2 + DTIC 1g/m2 Q3 weeks
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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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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Disease free survival
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Assessment method [1]
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Disease free survival will be measured from the data of randomization (as reference) to the date of recurrence or death, whichever occurs first.
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Timepoint [1]
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7 years from first patient in
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Secondary outcome [1]
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Overall survival (OS)
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Assessment method [1]
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OS will be measured from the date of randomization to the date of death, whatever the cause.
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Timepoint [1]
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8 years from first patient in
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Secondary outcome [2]
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Local recurrence free survival
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Assessment method [2]
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Local recurrence free survival will be measured from the date of randomization to the date of recurrence (local) or death, whichever occurs first.
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Timepoint [2]
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8 years from first patient in
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Secondary outcome [3]
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Recurrence free survival
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Assessment method [3]
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Recurrence free survival will be measured from the date of randomization to the date of recurrence (local or distant) or death, whichever occurs first.
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Timepoint [3]
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8 years from first patient in
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Secondary outcome [4]
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Distant metastases free survival
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Assessment method [4]
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Distant metastases free survival will be measured from the date of randomization to the date of distant metastases or death, whichever occurs first.
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Timepoint [4]
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8 years from first patient in
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Eligibility
Key inclusion criteria
- Histologically proven primary high risk leiomyosarcoma (LMS) or Liposarcoma (LPS) of
retroperitoneal space or infra-peritoneal spaces of pelvis.
- LMS:
- Any grade LMS can be included
- Minimum size of LMS tumor should be 5 cm
- LPS:
- Diagnosis should be confirmed based on MDM2 (Mouse double minute 2 homolog) and
CDK4 (Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while
proof of MDM2 amplification is highly recommended.
- All grade 3 DDLPS can be included.
- DDLPS with confirmed grade 2 on biopsy can be included when:
- The grade 2 DDLPS has an FNCLCC score=5 (Fédération Nationale des Centres de
Lutte Contre Le Cancer), has no necrosis on the biopsy but clear necrosis on
imaging.
- The tumors carry a high risk gene profile as determined by the Complexity
INdex in SARComas (CINSARC-high)
- Representative formalin fixed, paraffin embedded tumor blocks or unstained tissue
slides must be available at baseline for histological central review.
- Unifocal tumor
- Absence of extension through the sciatic notch or across the diaphragm
- Resectable tumor: resectability is based on pre-operative imaging (CT-abdomen,
potentially also with MRI) and has to be defined by the local treating sarcoma team. A
patients is not considered resectable when the expectation is that only an R2
resection is feasible.
- Criteria for non-resectability are:
- Involvement of the superior mesenteric artery, aorta, coeliac trunk and/or
portal vein
- Involvement of bone
- Growth into the spinal canal
- Progression of retro-hepatic inferior vena cava leiomyosarcoma towards the
right atrium
- Infiltration of multiple major organs like liver, pancreas and/or major
vessels
- Tumor not previously treated (no previous surgery (excluding diagnostic biopsy),
radiotherapy or systemic therapy)
- Patient must have radiologically measurable disease (RECIST 1.1), as confirmed by
imaging within the 28 days prior to randomization. CT thorax abdomen pelvis with IV
contrast is the preferred imaging modality. In case of any contra-indications (medical
or regulatory), it is allowed to perform a non-contrast CT thorax + MRI abdomen &
pelvis.
- = 18 years old (no upper age limit)
- WHO (World Health Organization) performance status = 2
- Adequate haematological and organ function:
- Haematological: haemoglobin > 9.0 g/dL or 5.6 mmol/L, absolute neutrophils > 1.5
x 109/L, platelets > 100 x 109/L Note: Platelet transfusions is allowed to
achieve these baseline values
- Renal: estimated glomerular filtration rate (eGFR) > 50 ml/min/m2; No proteinuria
CTCAE = grade 2;
- Hepatic: Bilirubin = 1.0 times upper limit of normal (1.0xULN) of institutional
limits, ALT (alanine aminotransferase) and/or AST (aspartate transaminase) =1.5 x
ULN. If isolated elevated bilirubin <2 x ULN and Gilberts syndrome suspected,
suggest repeating bloods after food. If bilirubin improves to meet the criteria
above this is acceptable. More severe persistent hepatic impairment of whatever
cause would exclude the patient from treatment till resolved.
- Heart: Clinically normal cardiac function based on left ventricular ejection
fraction (LVEF = 50%) as assessed either by multi-gated acquisition scan (MUGA)
or cardiac ultrasound and 12 lead ECG without clinically relevant abnormalities.
- American Society of Anesthesiologist (ASA) score < 3
- Women of child bearing potential (WOCBP) must have a negative serum pregnancy test
within 7 days prior to the first dose of study treatment or surgery.
Note: a woman is considered of childbearing potential (WOCBP), i.e. fertile, following
menarche and until becoming post menopausal unless permanently sterile.
Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral
oophorectomy.
A postmenopausal state is defined as no menses for 12 months without an alternative medical
cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be
used to confirm a post-menopausal state in women not using hormonal contraception or
hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single
FSH measurement is insufficient..
- Patients of childbearing / reproductive potential should use highly effective birth
control measures, as defined by the investigator, during the study treatment period
and for at least 6 months after the last dose of treatment or date of surgery. A
highly effective method of birth control is defined as a method which results in a low
failure rate (i.e. less than 1% per year) when used consistently and correctly. Such
methods include:
- Combined (oestrogen and progestogen containing) hormonal contraception associated
with inhibition of ovulation (oral, intravaginal, transdermal)
- Progestogen-only hormonal contraception associated with inhibition of ovulation
(oral, injectable, implantable)
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomized partner
- Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in
relation to the duration of the clinical trial and the preferred and usual
lifestyle of the patient)
- Female subjects who are breast feeding should discontinue nursing prior to the first
day of study treatment and until 6 months after the last study treatment.
- Before patient registration/randomization, written informed consent must be given
according to ICH/GCP, and national/local regulations.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Sarcoma originated from bone structure, abdominal or gynecological viscera
- Metastatic disease
- Tumors with extension through the sciatic notch or across the diaphragm
- Hypersensitivity to doxorubicin, ifosfamide, dacarbazine or to any of their
metabolites or to any of their excipients
- Persistent myelosuppression
- Myocardial infarction within the last 6 months
- Uncontrolled cardiac arrhythmia
- Previous treatment with maximum cumulative doses (450mg/m² Doxorubicin or equivalent
900mg/m² EpiADM) of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other
anthracyclines and anthracenediones
- Active and uncontrolled infections
- Vaccination with live vaccines within 30 days prior to study entry
- Inflammation of the urinary bladder (interstitial cystitis) and/or obstructions of the
urine flow.
- Other invasive malignancy within 5 years, with the exception of adequately treated
non-melanoma skin cancer, localized cervical cancer, localized and presumably cured
prostate cancer.
- Uncontrolled severe illness, infection,medical condition (including, uncontrolled
diabetes or hypertension), other than the Primary LPS or LMS of the retroperitoneum.
- Female patients who are pregnant or breastfeeding or female and male patients of
reproductive potential who are not willing to employ effective birth control method.
- Any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those conditions
should be discussed with the patient before randomization in the trial
- Known contraindication to imaging tracer and to MRI
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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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
Parallel
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Other design features
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Phase
Phase 3
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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
20/01/2021
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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
21/04/2028
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Princess Alexandra Hospital - University Of Queensland - Woolloongabba
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Recruitment hospital [2]
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Peter Maccallum Cancer Institute - Melbourne
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Recruitment hospital [3]
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Chris O'Brian Life House - Chris O'Brien Lifehouse - Camperdown
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Recruitment postcode(s) [1]
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QLD 4102 - Woolloongabba
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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2050 - Camperdown
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Recruitment outside Australia
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Wirral
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Funding & Sponsors
Primary sponsor type
Other
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Name
European Organisation for Research and Treatment of Cancer - EORTC
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Address
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Other
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Canadian Cancer Trials Group
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Other
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ECOG-ACRIN Cancer Research Group
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Other
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Anticancer Fund, Belgium
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Other
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Australia and New Zealand Sarcoma Association
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Other
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Japan Clinical Oncology Group
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative
chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk
DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease
free survival.
After confirmation of eligibility criteria, patients will be randomized to either the
standard arm or experimental arm.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04031677
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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EORTC HQ
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Phone
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+3227741611
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04031677
Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
VIC
Recruitment hospital [1]
89
Peter MacCallum Cancer Centre
Recruitment postcode(s) [1]
93
3000
Funding & Sponsors
Funding source category [1]
72
Government body
Name [1]
72
NHMRC - Medical Research Future Fund (MRFF) - 2020 Rare Cancers Rare Diseases and Unmet Need (RCRDUN)
Address [1]
72
GPO Box 1421 Canberra ACT 2601
Country [1]
72
Australia
Funding source category [2]
73
Other Collaborative groups
Name [2]
73
European Organisation for Research and Treatment of Cancer
Address [2]
73
Avenue Emmanuel Mounier 83/11 1200 Brussels Belgium
Country [2]
73
Belgium
Primary sponsor
Other Collaborative groups
Primary sponsor name
European Organisation for Research and Treatment of Cancer (EORTC)
Primary sponsor address
Avenue Emmanuel Mounier 83/11
1200 Brussels
Belgium
Primary sponsor country
Belgium
Secondary sponsor category [1]
74
Other Collaborative groups
Name [1]
74
Australia and New Zealand Sarcoma Association (ANZSA)
Address [1]
74
305 Grattan Street, Melbourne VIC 3000
Country [1]
74
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1]
47
Peter MacCallum Cancer Centre HREC
Address [1]
47
305 Grattan Street Melbourne VIC 3000
Country [1]
47
Australia
Date submitted for ethics approval [1]
47
11/06/2021
Approval date [1]
47
12/11/2021
Ethics approval number [1]
47
HREC/65094/PMCC
Public notes
Contacts
Principal investigator
Title
329
0
A/Prof
Query!
Name
329
0
Anne Hamilton
Query!
Address
329
0
Peter MacCallum Cancer Centre 305 Grattan Street Melbourne VIC 3000
Query!
Country
329
0
Australia
Query!
Phone
329
0
+61 3 85598339
Query!
Fax
329
0
Query!
Email
329
0
[email protected]
Query!
Contact person for public queries
Title
330
0
Ms
Query!
Name
330
0
Janina Chapman
Query!
Address
330
0
Clinical Trial Manager Australia and New Zealand Sarcoma Association 305 Grattan Street Melbourne VIC 3000
Query!
Country
330
0
Australia
Query!
Phone
330
0
+61 4 14316490
Query!
Fax
330
0
Query!
Email
330
0
[email protected]
Query!
Contact person for scientific queries
Title
331
0
A/Prof
Query!
Name
331
0
Anne Hamilton
Query!
Address
331
0
Peter MacCallum Cancer Centre 305 Grattan Street Melbourne VIC 3000
Query!
Country
331
0
Australia
Query!
Phone
331
0
+61 3 85598339
Query!
Fax
331
0
Query!
Email
331
0
[email protected]
Query!
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