NCT07831902招募中3 期
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (RAINBO) No Specific Molecular Profile (NSMP) - ORANGE Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 12
- 主要终点
- Recurrence free survival (RFS)
研究概览
简要总结
RAINBO NSMP-ORANGE aims to investigate if adjuvant radiotherapy with oral progestin tablets is as effective as radiotherapy with chemotherapy, whilst reducing toxicity and thus improving quality of life, in patients with high-risk NSMP endometrial cancer. Patients will be randomised to radiotherapy with chemotherapy (standard of care), or radiotherapy followed by oral progestin tablets.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Written informed consent and consent for data sharing for the overarching RAINBO programme
- •Histologically confirmed diagnosis of endometrial cancer (EC) of the following histotypes: endometrioid endometrial carcinoma, serous endometrial carcinoma, uterine clear cell carcinoma, dedifferentiated and undifferentiated endometrial carcinoma, uterine carcinosarcoma and mixed endometrial carcinomas of the aforementioned histotypes
- •Full molecular classification performed following the diagnostic algorithm described in WHO 2020 (5th Edition, IARC, Lyon, 2020, adapted from Vermij et al. 2020)
- •Hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy or sentinel node biopsy, without macroscopic residual disease after surgery
- •No distant metastases as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis within 8 weeks of randomisation). Whole-body PET-CT scan is acceptable if this is part of standard of care at participating sites
- •Age ≥ 18 years
- •WHO performance status 0 or 1
- •Expected start of adjuvant treatment within 10 weeks after surgery
- •Patients must be accessible for treatment and follow-up
- •Consent for the donation of a tissue block for translational research for the overarching RAINBO programme
- •FIGO (2018) stage II EC with substantial LVSI or stage III NSMP tumours
- •p53 wildtype, MMR proficient EC with no somatic pathogenic POLE variant (i.e. NSMP)
- •ER+ by IHC (10% threshold applied) or Allred score of ≥3
- •Absolute neutrophil count (ANC) ≥1.5 x 109 /l
- •Platelets ≥ 100 x 109 /L
- •Bilirubin ≤ 1.5 x UNL (or ≤ 3 x ULN for cases of known Gilbert's syndrome)
- •AST/ALT ≤ 2.5 x UNL
排除标准
- •Previous malignancy, except for non-melanoma skin cancer, in the past 5 years
- •Prior pelvic radiation
- •Active or recent arterial thromboembolic disease (e.g. angina, myocardial infarction) within previous 6 months
- •Thromboembolic event, e.g. pulmonary embolism or deep vein thrombosis, within previous 6 months
- •Impaired renal function: ≤50ml/min (EDTA clearance, or measured creatinine clearance) or creatinine clearance ≤60 ml/min (calculated according to Cockcroft gault)
- •Uncontrolled cardiac disease (defined as cardiac function which would preclude hydration during cisplatin administration and any contraindication to paclitaxel)
- •Peripheral neuropathy, ≥ grade 2
- •Inflammatory bowel disease
- •Known history of porphyria
- •History of active immune deficiency syndromes or uncontrolled HIV infection: HIV positive patients receiving effective antiretroviral therapy and CD4 count >200 may be included
- •Patients who have received a live attenuated vaccine within 2 weeks prior to planned treatment start
- •Any other condition which as per section 4.3 of the relevant SmPC or in the opinion of the investigator contraindicates the use of chemotherapy, radiotherapy and/or oral progestin tablets
- •The patient is currently participating in another interventional clinical trial or has received an investigational drug (either approved or not approved) in any prior clinical study within 5 half-lives prior to screening
研究组 & 干预措施
Arm A
Experimental
Adjuvant pelvic radiotherapy +/- vaginal brachytherapy followed by oral progestin tablets for 24 months (investigational arm)
干预措施: medroxyprogesterone acetate tablets OR megestrol acetate (Drug)
Arm B
Active Comparator
Adjuvant pelvic radiotherapy +/- vaginal brachytherapy with chemotherapy (cisplatin, carboplatin and paclitaxel, standard of care arm)
干预措施: Carboplatin + Paclitaxel (Drug)
Arm B
Active Comparator
Adjuvant pelvic radiotherapy +/- vaginal brachytherapy with chemotherapy (cisplatin, carboplatin and paclitaxel, standard of care arm)
干预措施: Cisplatin (Drug)
结局指标
主要结局
Recurrence free survival (RFS)
时间窗: 3 years
RFS is defined as the time from date of randomisation to date of recurrence or death from any cause.
次要结局
- Recurrence free survival (RFS)(5 years)
- Vaginal recurrence free survival (RFS)(3 years, 5 years)
- Pelvic recurrence free survival (RFS)(3 years, 5 years)
- Para-aortic nodal recurrence free survival (RFS)(3 years, 5 years)
- Distant recurrence free survival (RFS)(3 years, 5 years)
- Cancer-specific survival(3 years, 5 years)
- Overall survival(3 years, 5 years)
- Treatment-related toxicity (using the Common Terminology Criteria for Adverse Events [CTCAE] version 5.0)(3 years, 5 years)
- Health-related quality of life (using the validated common and endometrial cancer European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaires C30 and EN24)(3 years, 5 years)
研究者
研究点 (12)
Loading locations...
相似试验
尚未招募
Phase 3 4
RAINBO-p53abn-RED: A study to assess testing on maintenance drug olaparib versus observation after adjuvant chemoradiation for p53 mutant, high risk endometrial cancerCTRI/2024/12/078637Gustave Roussy554
尚未招募
3 期
Study of additional treatment after surgery in endometrial cancerCTRI/2024/08/072343Leiden University Medical Center316
尚未招募
1 期
A Phase 1 Study to Evaluate the Safety and Efficacy of OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.Ovarian CancerNCT07664735Outpace Bio, Inc.30
招募中
2 期
Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular ClassificationNCT07319429Fudan University260
尚未招募
不适用
A study comparing new and old methods (FIGO 2023 v/s FIGO 2009) for staging Endometrial Cancer and how these changes affects treatment and the role of molecular testingCTRI/2024/12/077849DR RAJKRISHNA B110