NL-OMON55931招募中2 期
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 - RAINBO POLEmut-BLUE trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational non invasive
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •- 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,
- •- 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.
排除标准
- •- 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
- •- 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).
研究者
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