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Not yet recruitingLast updated: 12 February 2024

TAPER: This study is evaluating the effectiveness of preventing cancer recurrence in people with endometrial cancer who have had prior surgery by using their tumour molecular status to determine whether they require further treatmentA Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)

Clinical summary


Peter MacCallum Cancer Centre Parkville and Moorabbin are recruiting to substudy two. This substudy is recruiting patients with p53wt/NSMP (p53wildtype/ no specific molecular profile) early-stage endometrial cancer who have had surgery (a hysterectomy and bilateral salpingo-oophorectomy). Tissue is removed as part of this procedure and will be analysed in the pathology laboratory to guide the doctor to decide whether or not additional treatment. If additional treatment is required, participants will receive a type of radiation therapy called vaginal brachytherapy.


This trial is treating patients with endometrial cancer that has been surgically removed


Female Reproductive System Cancers Gynaecological





Trial Acronym


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Trial Identifiers

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Trial sponsor

Canadian Cancer Trials Group

Scientific Title

A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)



  • 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


  • 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)


  • You have had a certain type of treatment or surgical procedure.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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