An Adaptative Randomized Phase II Study on the Timing of FOLFOX for Patients With Operable Stage III Rectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles
研究概览
简要总结
This study is proposed to evaluate whether giving part of the chemotherapy prior to radiotherapy and surgery (as opposed to standard of care, which involves giving all the chemotherapy after radiotherapy and surgery) for patients with node positive operable rectal cancer will result in higher patient compliance to chemotherapy.
详细描述
In recent randomized studies with preoperative combined chemotherapy and external beam radiation (EBRT/CT) with total mesorectal excision (TME surgery), the compliance to adjuvant chemotherapy ranged from 42.9% to 70%. This low compliance rate could influence the efficacy of chemotherapy. This is quite unique to patients with rectal cancer, since compliance is not a major issue in patients with colon cancer, belonging to the same age group. Therefore, it is reasonable to postulate that this difference might due to the additive toxicity burden of neoadjuvant EBRT/CT and TME.
In this randomized phase II study, compliance to chemotherapy will be compared in the two groups: In the first group, patients will receive half of their chemotherapy regimen in neoadjuvant and half in adjuvant; and, in the second group, patients will be receiving all their chemotherapy in adjuvant. Furthermore, brachytherapy will be used to deliver radiotherapy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Pathology: Adenocarcinoma of the rectum.
- •T2 (CRM+) or T3 tumour at ≤ 10 cm from the A-V margin (as per MRI criteria)
- •Evidence of perirectal nodes on MRI or EUS (N1 or N2), any CRM+ and N0 tumor, or any EMVI+ tumor
- •Tumors with an adequate lumen to allow the positioning of the Oncosmart intracavitary mould applicator (e.g. non obstructive tumor).
- •Tumour of less than 3.5 cm thickness documented at the CT Simulator.
- •Patient should be a suitable candidate for surgery and chemotherapy.
- •WHO performance status 0-2
- •Age > 18 years.
- •Written informed consent.
- •Adequate birth control measures in women with childbearing potential.
排除标准
- •Patients with positive extramesorectal or pelvic nodes (e.g. iliac, lateral).
- •Evidence of distant metastases (M1).
- •Previous pelvic radiation.
- •Other cancers except for basal cell carcinoma of the skin or CIS of the cervix.
- •Presence of multiples small bowel loops trapped within the immediate tumor bed (post hysterectomy or prostatectomy).
- •Extension of malignant disease to the anal canal
- •Patients with severe co-morbid conditions (recent MI, infections, AIDS, etc)
研究组 & 干预措施
A - neoadjuvant chemotherapy
Patients in arm A will receive 6 cycles of FOLFOX chemotherapy prior to radiotherapy and surgery as well as 6 cycles of chemotherapy in adjuvant
干预措施: FOLFOX (Drug)
A - neoadjuvant chemotherapy
Patients in arm A will receive 6 cycles of FOLFOX chemotherapy prior to radiotherapy and surgery as well as 6 cycles of chemotherapy in adjuvant
干预措施: high dose rate endorectal brachytherapy (Radiation)
Arm B - adjuvant chemotherapy
Patients in arm B will receive 12 cycles of FOLFOX after radiotherapy and surgery
干预措施: FOLFOX (Drug)
Arm B - adjuvant chemotherapy
Patients in arm B will receive 12 cycles of FOLFOX after radiotherapy and surgery
干预措施: high dose rate endorectal brachytherapy (Radiation)
结局指标
主要结局
Compliance to chemotherapy - patients receiving at least 85% of planned full-dose of chemotherapy prescribed at each cycle for the 12 cycles
时间窗: 1 year post diagnosis
次要结局
- Disease free survival rate (local recurrence and metastases)(5 years post surgery)
- Overall survival rate(5 years post surgery)
研究者
Dr. Te Vuong
Director Radiation Oncology Department
Sir Mortimer B. Davis - Jewish General Hospital