Evaluation of the Interval Between Chemoradiotherapy and Surgery on Locally Advanced Rectal Cancer Response:a Multicentric Randomized Phase III Study
试验速览
- 阶段
- 不适用
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Complete response (CR) ypT0N0
研究概览
简要总结
This is a randomized multicentric clinical trial in patients affected by resectable rectal cancer, cT2N1-2, cT3N0-2, MRF -, aiming to evaluate the impact of the interval between chemoradiotherapy and surgery on the pathological response.
Patients will undergo a neoadjuvant chemoradiotherapy treatment and those achieving a major or complete clinical and instrumental response will then be randomized and submitted to surgery with two options: the first group will be operated after an interval of 9-11 weeks, while the second will undergo surgery at 13-16 weeks, after a further clinical and instrumental re-evaluation 11-12 weeks after the end of chemoradiotherapy.
详细描述
The proposed study is a randomized multicentric phase III study. The Patients included in the study will undergo a chemoradiotherapy neoadjuvant treatment.
Patients will undergo a clinical-instrumental restaging at 7-8 weeks and will be randomized in two groups in case of major or complete response:
- Surgery 9-11 weeks after the end of neoadjuvant treatment
- Second clinical and instrumental re-evaluation after 11-12 weeks and then surgery 13-16 weeks after the end of chemoradiotherapy.
Only patients who underwent preoperative chemoradiotherapy and achieved a complete or major response at the clinical-instrumental restaging 7-8 weeks after the end of neoadjuvant treatment will be included in the study.
The control arm of the BRIDGE-1 study is represented by patients undergoing surgery 9-11 weeks after the end of chemoradiotherapy, whose major/complete response has to be assessed with clinical-instrumental exams to be performed 7-8 weeks after the end of chemoradiotherapy.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG Performance Status 0-1
- •Histological confirmation of Adenocarcinoma
- •Rectal tumor localized within 12 cm from the internal anal sphincter (IAS)
- •Clinical stage cT2N1-2, M0; cT3, N0-N2, M0 and MRF - , EMVI -
- •Absence of major comorbidities contraindicating oncological treatments
- •Major/complete clinical-instrumental response after CRT treatment
- •Informed consent acquisition
排除标准
- •cT4 and/or mesorectal fascia involvement (MRF+) and or EMVI +
- •T localized at a distance > 12 cm from the internal anal sphincter (IAS)
- •Presence of extramesorectal nodes
- •Presence of distant metastases
- •Pregnancy or breastfeeding status
- •Diagnosis of tumor in other sites treated within the last five years, with the exception of basal cell skin carcinoma or in situ carcinoma of the cervix
- •Absolute contraindication to pelvic radiotherapy, chemotherapy and/or surgery
- •Contraindication to magnetic resonance imaging and/or endoscopy
- •Informed consent absence
- •Partial response, "no-change" or disease progression at restaging after 7-8 weeks from CRT end
结局指标
主要结局
Complete response (CR) ypT0N0
时间窗: 9-16 weeks: surgery
Absence of tumoral cells in the rectum and mesorectal nodes, examined by the pathologist
TRG (Tumor Regression Grade)
时间窗: 9-16 weeks: surgery
Histological assessment of the response of rectal cancer to neoadjuvant treatment
次要结局
- Overall survival(24-60 months)
- Disease free survival(24-60 months)
- Local recurrence free survival(24-60 months)
- Metastasis free survival(24-60 months)
- Concordance between major clinical response (ymCR) or complete clinical response (ycCR) at imaging and ypCR(24-60 months)
- Colostomy free survival(24-60 months)
- Impact of therapy on bowel function(24-60 months)
- Impact of therapy on fecal continence(24-60 months)
- Impact of therapy on sexual activity(24-60 months)
- Impact of therapy on quality of life (QoL)(24-60 months)
研究者
GAMBACORTA MARIA ANTONIETTA
Professor, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS