| CTRI Number |
CTRI/2024/12/078637 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
24/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
RAINBO-p53abn-RED: A study to assess testing on maintenance drug olaparib versus observation after adjuvant chemoradiation for p53 mutant, high risk endometrial cancer |
|
Scientific Title of Study
|
Refining Adjuvant treatment IN endometrial cancer Based
On molecular features, TransPORTEC platform trials –
p53abn - RED
Randomized phase III trial testing maintenance olaparib
versus observation after adjuvant chemoradiation for
p53abn endometrial cancer |
| Trial Acronym |
RAINBO-RED |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2023-503886-44-00 |
EudraCT |
| CSET 2023/3603,Version N°1.2 du 28/11/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asima Mukhopadhyay |
| Designation |
Consultant and Director |
| Affiliation |
KolGOTrg |
| Address |
Room 1 B Department of gynecologic oncology KolGOTrg office Street no 271 Action Area 1 Newtown
Kolkata
WEST BENGAL
700156
India |
| Phone |
07044088132 |
| Fax |
|
| Email |
asima.mukhopadhyay@kolgotrg.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Asima Mukhopadhyay |
| Designation |
Consultant and Director |
| Affiliation |
KolGOTrg |
| Address |
Room 1 B Department of gynecologic oncology KolGOTrg office Street no 271 Action Area 1 Newtown
Kolkata
WEST BENGAL
700156
India |
| Phone |
07044088132 |
| Fax |
|
| Email |
asima.mukhopadhyay@kolgotrg.org |
|
Details of Contact Person
Public Query
|
| Name |
Dona Chakraborty |
| Designation |
Research Administrator |
| Affiliation |
KolGOTrg |
| Address |
Room 1 B Department of gynecologic oncology KolGOTrg office Street no 271 Action Area 1 Newtown
Kolkata
WEST BENGAL
700156
India |
| Phone |
8918633700 |
| Fax |
|
| Email |
donachakraborty9366@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gustave Roussy
114 rue Edouard Vaillant
Pin 94805 Villejuif
France, Europe |
|
|
Primary Sponsor
|
| Name |
Gustave Roussy |
| Address |
114 rue Edouard Vaillant
Villejuif Cedex France Pin 94805
Europe |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| KolGoTrg |
DD92 Street No 271 Action Area 1 Newtown Kolkata 700156 |
|
|
Countries of Recruitment
|
India
Canada
France
Netherlands
United Kingdom |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul ROychowdhury |
Saroj Gupta Cancer Centre and Research Institute |
2nd floor, Department of gynecological oncology,Mahatma Gandhi Rd, Cancer Hospital, Greater Bakul Bithi, Thakurpukur, Kolkata,
Kolkata
WEST BENGAL |
9874536488
rroychowdh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC OF SAROJ GUPTA CANCER CENTRE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C539||Malignant neoplasm of cervix uteri, unspecified, (2) ICD-10 Condition: C541||Malignant neoplasm of endometrium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Maintenance therapy with olaparib |
Route:orally, dose: daily dosing in maintenance setting Timeframe: Drug for one year, treatment for 3 years and followup for one year.
To assess whether maintenance therapy with olaparib improves recurrence-free survival (RFS), as compared to observation after chemo-radiotherapy in patients with p53abn HREC |
| Comparator Agent |
Observation after chemo-radiotherapy |
Route:orally, dose: daily dosing in maintenance setting, Timeframe: Drug for one year, treatment for 3 years and followup for one year.
To assess whether maintenance therapy with olaparib improves recurrence-free survival (RFS), as compared to observation after chemo-radiotherapy in patients with p53abn HREC |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
WHO Performance score 0-1
Histologically confirmed Stage I to III EC with myometrial invasion
Molecular classification p53abn EC
Body weight less than 30 kg
|
|
| ExclusionCriteria |
| Details |
Major surgical procedure (as defined by the Investigator) within 2 weeks prior randomization and patients must have recovered from any effects of any major surgery.
History of allogenic organ transplantation.
Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, Patient with severe hepatic impairment
Any previous treatment with a PARP inhibitor, including olaparib.
History of active primary immunodeficiency
History or evidence of hemorrhagic disorders within 6 months prior to randomization
Patients with myelodysplastic syndrome/acute myeloid leukemia history or with features suggestive of MDS or AML.
Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
Active infection including tuberculosis
Concomitant use of known strong CYP3A inhibitors or inducers
Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
Treatment with an unlicensed or investigational product within 4 weeks of trial entry.
Pregnant and breastfeeding patients
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Recurrence free survival (RFS) in patients with p53abn EC, as assessed by the investigator. |
Baseline to 12 months- Recurrence free survival (RFS) in patients with p53abn EC, as assessed by the investigator. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Overall survival (OS)
|
0-36 months |
Disease-specific survival
|
0-36months |
| Vaginal recurrence-free survival |
0-36 months |
Pelvic recurrence-free survival
|
0-36 months |
| Distant recurrence-free survival |
0-36 months |
|
|
Target Sample Size
|
Total Sample Size="554"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/11/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The endometrial cancer classification has recently been changed by the integration of surrogate molecular markers allowing the identification of four distinct endometrial cancer subtypes. Evidence from our group show that not only prognosis, but also adjuvant treatment benefit depends on which molecular EC subtype a patients has. High risk EC (HREC) patients belonging to the p53abn EC subgroup are the ones who benefited the most from concurrent chemoradiation suggesting frequent HR deficiency. We hypothesize that patients with early p53abn EC will benefit from olaparib as maintenance resulting in an increase in RFS and ultimately OS. |