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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.

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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.

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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).
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    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

    Study type

    TREATMENT

    phase

    Phase

      PHASE2

    trial

    Trial ID

    NCT05640999

    Intervention or treatment

    RADIATION: Vaginal brachytherapy

    RADIATION: Adjuvant radiotherapy (EBRT +/- brachytherapy)

    OTHER: Observation

    Conditions

    • Endometrial Cancer
    Image related to Endometrial Cancer
    • Condition: Endometrial Cancer

    • RADIATION: Vaginal brachytherapy and other drugs

    • Westmead, New South Wales, Australia and more

    • Sponsor: Canadian Cancer Trials Group

    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

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    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/ArmIntervention/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 MeasurePrimary Outcome DescriptionPrimary 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 statusNot Specified3 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Estimate the rate of isolated vaginal recurrence at 3 yearsNot Specified3 years
    Estimate the rate of para-aortic recurrence at 3 yearsNot Specified3 years
    Estimate the rate of distant metastasis at 3 yearsNot Specified3 years
    Estimate recurrence-free survivalNot Specified9 years
    Estimate endometrial cancer-specific survivalNot Specified9 years
    Estimate overall survivalNot Specified9 years
    Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence InventoryNot Specified9 years

    Frequently Asked Questions

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    References

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

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