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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/NCT05862051
Registration number
NCT05862051
Ethics application status
Date submitted
8/12/2022
Date registered
17/05/2023
Date last updated
17/10/2023
Titles & IDs
Public title
RESOLUTE Trial Aims to Investigate the Value of Adding Local Ablative Treatment to Standard Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
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Scientific title
Randomised Phase II Trial to Evaluate Progression-Free Survival in Integrating Local Ablative Therapy With First-Line Systemic Treatment for Unresectable Oligometastatic Colorectal Cancer
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Secondary ID [1]
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RESOLUTE
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Universal Trial Number (UTN)
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Trial acronym
RESOLUTE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
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Oligometastatic Disease
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Local Ablative Therapy
Treatment: Surgery - Standard first-line systemic treatment
Experimental: Local ablative therapies (LAT) arm - A maximum of three Local ablative therapy (LAT) modalities can be administered for each participant, with a maximum of 2 modalities per organ, provided all LAT can be delivered within 12 weeks and participant can safely resume systemic treatment within 16 weeks from randomisation.
After completing LAT, participant is to resume a further two to three months of first-line systemic treatment to a total of 6 months (including the initial 3-4 months of treatment). For patients receiving a doublet or triplet regimen, treatment may be de-escalated to maintenance fluoropyrimidine +/- biologics or anti-EGFR monotherapy at any point after trial entry at clinician discretion. The treating clinician may choose to discontinue systemic treatment following LAT for patients who have experienced prior intolerable toxicity.
Placebo Comparator: Control arm - The first-line systemic treatment will be standard of care as determined by the treating clinician. The following standard chemotherapy regimens are allowed: single agent fluoropyrimidine, CAPOX, FOLFOX, FOLFIRI, CAPIRI or FOLFOXIRI. Treatment with a biologic is allowed including bevacizumab or an anti-EGFR antibody (cetuximab or panitumumab). For patients receiving a doublet or triplet regimen, treatment may be de-escalated to maintenance fluoropyrimidine +/- biologics or anti-EGFR monotherapy at any point after trial entry at clinician discretion.
Treatment: Surgery: Local Ablative Therapy
LAT modalities allowed include surgical resection, stereotactic radiotherapy (SRT), laparoscopic or percutaneous thermal ablation [radiofrequency ablation (RFA) or microwave ablation (MWA)]. The LAT modalities will be delivered by specialists in the field (surgeons, radiation oncologists and/or interventional radiologists). The precise mode of delivery and number of times the LAT modality is delivered is case-dependent and is determined at a multi-disciplinary meeting (MDM).
Treatment: Surgery: Standard first-line systemic treatment
Standard of care as determined by the treating clinician. The following standard chemotherapy regimens are allowed: single agent fluoropyrimidine, CAPOX, FOLFOX, FOLFIRI, CAPIRI or FOLFOXIRI. Treatment with a biologic is allowed including bevacizumab or an anti-EGFR antibody (cetuximab or panitumumab). For patients receiving a doublet or triplet regimen, treatment may be de-escalated to maintenance fluoropyrimidine +/- biologics or anti-EGFR monotherapy at any point after trial entry at clinician discretion.
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Intervention code [1]
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Treatment: Surgery
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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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Progression free survival (PFS)
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Assessment method [1]
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To compare the efficacy of metastasis-directed LAT following initial standard first-line systemic treatment vs continued first-line systemic treatment alone, as measured by Progression-Free Survival (PFS)
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Timepoint [1]
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12 Months from randomisation
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Secondary outcome [1]
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Overall survival
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Assessment method [1]
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To compare the efficacy of LAT following initial standard first-line systemic treatment, compared to continued first-line systemic treatment alone, as measured by Overall Survival (OS)
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Timepoint [1]
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12 Months from randomisation and through study completion, an average of 1 year
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Secondary outcome [2]
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Efficacy of local ablative therapy
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Assessment method [2]
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To compare the efficacy of LAT following initial standard first-line systemic treatment, compared to continued first-line systemic treatment alone, on:
time to development of new metastatic lesions.
time to initiation of 2nd line systemic treatment.
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Timepoint [2]
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12 Months from randomisation and through study completion, an average of 1 year
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Secondary outcome [3]
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Time to progression following local ablative therapy
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Assessment method [3]
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To assess the time to progression of LAT treated lesions.
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Timepoint [3]
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Through study completion, an average of 1 year
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Secondary outcome [4]
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Systemic treatment-free interval
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Assessment method [4]
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To compare systemic treatment-free interval between the two treatment groups.
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Timepoint [4]
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Through study completion, an average of 1 year
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Secondary outcome [5]
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Rate of high-grade toxicities
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Assessment method [5]
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To assess and compare rate of high-grade (Grade 3-5) toxicities between the two treatment groups.
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Timepoint [5]
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Through study completion, an average of 1 year
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Secondary outcome [6]
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Quality of life measure
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Assessment method [6]
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To compare quality of life measures between the two treatment groups using patient questionnaire - The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) using the 4-point ordinal scale (not at all, a little, quite a bit and very much)
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Timepoint [6]
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Through study completion, an average of 1 year
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Eligibility
Key inclusion criteria
- Metastatic colorectal adenocarcinoma that is not amenable to potentially oncological
curative surgery alone.
- Primary tumour must be controlled if the primary is intact, with no evidence of
progression at primary site prior to study entry
- Imaging demonstrating ongoing treatment benefit (partial response or stable disease as
per RECIST criteria) after 3-4 months of standard first-line systemic treatment.
- At least one metastatic lesion detected on CT +/- FDG-PET scan prior to first line
systemic treatment AND on screening FDG-PET and CT scans, meeting the following
criteria:
1. max of 3 lesions per organ except for the liver and lung
2. max of 5 lesions in the lung
3. no limitation to the number of liver lesions provided they are all amenable to
LAT
4. max of 3 involved organs including a lymph node station
5. only one lymph node station involvement is allowed
6. for patients with liver metastases, a quadruple phase contrast enhanced CT or MRI
liver is required to fully stage the liver; this can be performed prior to or
within 4 weeks of commencing first line systemic treatment
7. staging FDG-PET scan is encouraged and can be performed prior to or within 4
weeks of commencing first line systemic treatment
- All lesions can be safely treated by LAT as determined by multidisciplinary team
meeting.
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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
- Deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-high) tumour
- BRAFV600E mutated tumour
- Concurrent or previous other malignancy within 2 years of study entry, except
curatively treated basal or squamous cell skin cancer, prostate intraepithelial
neoplasm, carcinoma in-situ of the cervix, Bowen's disease or prostate cancer with a
Gleason score =6.
- Presence of brain, peritoneal, omental or ovarian metastases
- Malignant pleural effusion or ascites.
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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
Not Applicable
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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
14/12/2021
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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
14/06/2025
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Actual
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Sample size
Target
75
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Border Medical Oncology - Albury
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Recruitment hospital [2]
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Bendigo Hospital - Bendigo
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Recruitment hospital [3]
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Eastern Health - Box Hill
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Recruitment hospital [4]
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The Northern Hospital - Epping
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Recruitment hospital [5]
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St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [6]
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Peter MaCallum Cancer Centre - Melbourne
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Recruitment hospital [7]
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Peninsula Health - Rosebud
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Recruitment hospital [8]
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Western Health - Saint Albans
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Recruitment hospital [9]
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Northeast Health Wangaratta - Wangaratta
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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3550 - Bendigo
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Recruitment postcode(s) [3]
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3128 - Box Hill
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Recruitment postcode(s) [4]
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3076 - Epping
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment postcode(s) [6]
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3000 - Melbourne
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Recruitment postcode(s) [7]
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3940 - Rosebud
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Recruitment postcode(s) [8]
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3021 - Saint Albans
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Recruitment postcode(s) [9]
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3677 - Wangaratta
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australasian Gastro-Intestinal Trials Group
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Walter and Eliza Hall Institute of Medical Research
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Cancer Council Victoria
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study aims to assess the clinical benefit of local ablative therapy (LAT) following
initial standard first-line systemic treatment including the impact on survival, compared to
continued standard first-line systemic treatment for oligometastatic colorectal cancer.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05862051
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sukanya Sathyamurthie
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Address
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Country
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Phone
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+61 2 7208 2719
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Fax
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Email
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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/NCT05862051
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