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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05640999


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05640999
Ethics application status
Date submitted
29/11/2022
Date registered
7/12/2022
Date last updated
12/06/2024

Titles & IDs
Public title
Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Scientific title
A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
Secondary ID [1] 0 0
NRG-GY032
Secondary ID [2] 0 0
EN10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometrial Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Vaginal brachytherapy
Treatment: Other - Adjuvant radiotherapy (EBRT +/- brachytherapy)
Other interventions - Observation

Experimental: Sub-study A: RAINBO BLUE Cohort A1 - Observation

Experimental: Sub-Study A: RAINBO BLUE Cohort A2 Exploratory - Observation or Adjuvant Radiotherapy

Experimental: Sub-Study B: TAPER - Observation or Vaginal Brachytherapy


Treatment: Other: Vaginal brachytherapy
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids

Treatment: Other: Adjuvant radiotherapy (EBRT +/- brachytherapy)
Treatment is to be delivered using 4-18 MV photons. MV, kV or CBCT imaging capabilities are required. Planning systems with capability for DICOM data transfer must be used.

Other interventions: Observation
Observation
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Estimate the rate of isolated vaginal recurrence at 3 years
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Estimate the rate of para-aortic recurrence at 3 years
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Estimate the rate of distant metastasis at 3 years
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Estimate recurrence-free survival
Timepoint [4] 0 0
9 years
Secondary outcome [5] 0 0
Estimate endometrial cancer-specific survival
Timepoint [5] 0 0
9 years
Secondary outcome [6] 0 0
Estimate overall survival
Timepoint [6] 0 0
9 years
Secondary outcome [7] 0 0
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory
Timepoint [7] 0 0
9 years

Eligibility
Key inclusion criteria
* Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery.
* Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
* Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Patients' age must be = 18 years.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
* Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language
* Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
* Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
* Prior pelvic radiation.
* Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for = 5 years.
* Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan) (

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
325
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [3] 0 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3053 - Parkville
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Netherlands
State/province [5] 0 0
Limburg
Country [6] 0 0
Netherlands
State/province [6] 0 0
Noord Brabant
Country [7] 0 0
Netherlands
State/province [7] 0 0
Leiden
Country [8] 0 0
Netherlands
State/province [8] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Other
Name
Canadian Cancer Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Canadian Cancer Clinical Trials Network
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies

* EN10.A/RAINBO BLUE: POLE-mutated EC
* EN10.B/TAPER: p53 wildtype / NSMP EC
Trial website
https://clinicaltrials.gov/study/NCT05640999
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kathy Han
Address 0 0
University Health Network, Princess Margaret Hospital, Toronto ON Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wendy Parulekar
Address 0 0
Country 0 0
Phone 0 0
613-533-6430
Fax 0 0
Email 0 0
wparulekar@ctg.queensu.ca
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05640999

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 172
Westmead Hospital
Recruitment postcode(s) [1] 173
2145
Funding & Sponsors
Primary sponsor
Other Collaborative groups
Primary sponsor name
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Primary sponsor address
Level 6, Lifehouse 119-143 Missenden Road Camperdown NSW 2050
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 72
WSLHD HREC
Address [1] 72
Country [1] 72
Australia
Date submitted for ethics approval [1] 72
20/07/2023
Approval date [1] 72
13/10/2023
Ethics approval number [1] 72
 
Public notes

Contacts
Principal investigator
Title 425 0
Prof
Name 425 0
Alison Brand
Address 425 0
Country 425 0
Australia
Phone 425 0
Fax 425 0
Email 425 0
alison.brand@health.nsw.gov.au
Contact person for public queries
Title 426 0
Mrs
Name 426 0
Lisa Bailey
Address 426 0
Country 426 0
Australia
Phone 426 0
Fax 426 0
Email 426 0
EN.10@anzgog.org.au
Contact person for scientific queries
Title 427 0
Name 427 0
Address 427 0
Country 427 0
Phone 427 0
Fax 427 0
Email 427 0