A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 393
- 试验地点
- 196
- 主要终点
- Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
- •Prior pelvic radiation.
- •Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other 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)
- •Patients with a documented positive surgical margin.
- •Patients with a documented positive peritoneal washings, if performed.
研究组 & 干预措施
Sub-Study A: RAINBO BLUE Cohort A2
Observation or Adjuvant Radiotherapy
干预措施: Adjuvant radiotherapy (EBRT +/- brachytherapy) (Radiation)
Sub-Study A: RAINBO BLUE Cohort A2
Observation or Adjuvant Radiotherapy
干预措施: Observation (Other)
Sub-Study B: TAPER
Observation or Vaginal Brachytherapy
干预措施: Observation (Other)
Sub-Study B: TAPER
Observation or Vaginal Brachytherapy
干预措施: Vaginal brachytherapy (Radiation)
Sub-study A: RAINBO BLUE Cohort A1
Observation
干预措施: Observation (Other)
结局指标
主要结局
Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status
时间窗: 3 years
次要结局
- Estimate recurrence-free survival(9 years)
- Estimate the rate of distant metastasis at 3 years(3 years)
- Estimate overall survival(9 years)
- Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory(9 years)
- Estimate the rate of isolated vaginal recurrence at 3 years(3 years)
- Estimate the rate of para-aortic recurrence at 3 years(3 years)
- Estimate endometrial cancer-specific survival(9 years)