Save

Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

PHASE2RECRUITING

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.

Simpliy with AI

Study details:

This study is being done in order to find out if this new approach is better or worse than the usual approach for early-stage endometrial cancer. The usual approach is defined as the care most people get for early-stage endometrial cancer. The usual approach for patients who are not in a study is treatment with surgery.

Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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).

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Female

Things to know

Study dates

Study start: 2022-12-19

Primary completion: 2028-12-31

Study completion finish: 2029-06-30

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05640999

Intervention or treatment

RADIATION: Vaginal brachytherapy

RADIATION: Adjuvant radiotherapy (EBRT +/- brachytherapy)

OTHER: Observation

Conditions

• Endometrial Cancer

Condition: Endometrial Cancer
RADIATION: Vaginal brachytherapy and other drugs
Westmead, New South Wales, Australia and more
Sponsor: Canadian Cancer Trials Group

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Westmead Hospital

Research sites nearby

Select from list below to view details:

Westmead Hospital
Westmead, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Royal Brisbane and Womens Hospital
Herston, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Sub-study A: RAINBO BLUE Cohort A1 Observation	OTHER: Observation Observation
EXPERIMENTAL: Sub-Study A: RAINBO BLUE Cohort A2 Exploratory Observation or Adjuvant Radiotherapy	RADIATION: 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.
EXPERIMENTAL: Sub-Study B: TAPER Observation or Vaginal Brachytherapy	RADIATION: Vaginal brachytherapy Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status	Not Specified	3 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Estimate the rate of isolated vaginal recurrence at 3 years	Not Specified	3 years
Estimate the rate of para-aortic recurrence at 3 years	Not Specified	3 years
Estimate the rate of distant metastasis at 3 years	Not Specified	3 years
Estimate recurrence-free survival	Not Specified	9 years
Estimate endometrial cancer-specific survival	Not Specified	9 years
Estimate overall survival	Not Specified	9 years
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory	Not Specified	9 years

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER