Health TrialsbyHealthPanel

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

ConditionEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCanadian Cancer Trials Group

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.

Prior pelvic radiation.

Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other 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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vaginal brachytherapy

    Radiation

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

  • Adjuvant radiotherapy (EBRT +/- brachytherapy)

    Radiation

    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.

  • Observation

    Other intervention

    Observation

Treatment groups

393 Participants
are divided into 3 treatment groups
Group A: Sub-study A: RAINBO BLUE Cohort A1Experimental treatment 1 intervention
Group B: Sub-Study A: RAINBO BLUE Cohort A2Experimental treatment 2 interventions
Group C: Sub-Study B: TAPERExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status

Time frame
3 years

Secondary outcomes

1

Estimate the rate of isolated vaginal recurrence at 3 years

Time frame
3 years
2

Estimate the rate of para-aortic recurrence at 3 years

Time frame
3 years
3

Estimate the rate of distant metastasis at 3 years

Time frame
3 years
4

Estimate recurrence-free survival

Time frame
9 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Canadian Cancer Trials Group

Lead sponsor

Canadian Cancer Clinical Trials Network

Collaborator

Australia New Zealand Gynaecological Oncology Group

Collaborator

Gustave Roussy, Cancer Campus, Grand Paris

Collaborator

Leiden University Medical Center

Collaborator

Mario Negri Gynecologic Oncology group (MaNGO)

Collaborator

NRG Oncology

Collaborator

Philipps University Marburg

Collaborator

University College, London

Collaborator

Source ClinicalTrials.gov
Apply now