A PHASE II STUDY OF TAILORED ADJUVANT THERAPY IN POLE-MUTATED AND p53-WILDTYPE/NSMP EARLY STAGE ENDOMETRIAL CANCER (RAINBO BLUE & TAPER) SUBSTUDY A: RAINBO POLEmut-BLUE: Refining Adjuvant treatment IN endometrial cancer Based On molecular features (RAINBO) TransPORTEC platform trials
- Conditions
- cancer of the wombmalignancy of the uterus10038594
- Registration Number
- NL-OMON55931
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Protocol page 9/10
- Patients must have had surgery consisting of hysterectomy (total abdominal,
laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph
node dissection can be performed as per institutional standards (sentinel or
full lymphadenectomy). 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
- Patients* age must be >= 18 years.
- Patient consent must be appropriately obtained in accordance with applicable
local and regulatory requirements. Each patient must sign a consent form prior
to enrollment in the trial to document their willingness to participate. A
similar process must be followed for sites outside of Canada as per their
respective cooperative group*s procedures.
- 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. The baseline assessment must be completed within required
timelines, prior to enrollment. Inability (lack of comprehension in English or
French, or other equivalent reason such as cognitive issues or lack of
competency) to complete the questionnaires will not make the patient ineligible
for the study. However, ability but unwillingness to complete the
questionnaires will make the patient ineligible.
- Patients must be accessible for treatment and follow-up. Patients enrolled on
this trial must be treated and followed at the participating centre. This
implies there must be reasonable geographical limits placed on patients being
considered for this trial. The patient*s city of residence may be required to
verify their geographical proximity. (Call the CCTG office (613-533-6430) if
questions arise regarding the interpretation of this criterion.) Investigators
must assure themselves the patients enrolled on this trial will be available
for complete documentation of the treatment, adverse events, and follow-up.
Patients must agree to return to their primary care facility for any adverse
events which may occur through the course of the trial.
- 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) (see the radiology timeline outlined in Section 5).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>3-year pelvic recurrence</p><br>
- Secondary Outcome Measures
Name Time Method <p>5-year pelvic recurrence, 3- and 5-year RFS, decisional conflict, and fear of<br /><br>recurrence. 3- and 5-year vaginal recurrence-free survival, distant<br /><br>recurrence-free survival, endometrial cancer-specific survival, overall<br /><br>survival, treatment-related toxicity (using the Common Terminology Criteria for<br /><br>Adverse Events (CTCAE) version 5) and health-related quality of life (using the<br /><br>common and endometrial cancer European Organization for Research and Treatment<br /><br>of Cancer (EORTC) Quality of Life Questionnaires C30 and EN24).</p><br>