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

Conditions

• Endometrial Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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
  Observation

Study Details

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

Key Dates

Start date

Dec 19, 2022

Status verified

Apr 2026

Primary completion

Dec 31, 2028

Completion

Jun 30, 2029

Study Design

Enrollment

393 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Sub-study A: RAINBO BLUE Cohort A1
  Observation
• Experimental: Sub-Study A: RAINBO BLUE Cohort A2
  Observation or Adjuvant Radiotherapy
• Experimental: Sub-Study B: TAPER
  Observation or Vaginal Brachytherapy

Primary Outcome Measure

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 ]

Central Contacts

• Wendy Parulekar
  613-533-6430
  [email protected]

Locations (68)

Find similar trials in Anchorage, AK

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