Multicenter Randomized Controlled Phase III Trial Comparing Ileostomy Closure Before or After Adjuvant Therapy in Patients Operated for Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 28
- 主要终点
- Percentage of participants with good compliance to adjuvant therapy
研究概览
简要总结
This is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it). After a curative resection for rectal cancer and temporary ileostomy, 270 patients with indication to adjuvant chemotherapy will be randomized to early (before starting adjuvant treatment) or late (after adjuvant treatment completion) stoma closure. Primary end point will the compliance to adjuvant therapy. Secondary endpoint will include quality of life and bowel function evaluation, postoperative morbidity, chemotherapy toxicity, oncological outcomes and costs comparison.
详细描述
Diverting ileostomy is effective in reducing severity of anastomotic complications in rectal low anterior resections and it is therefore widely used especially after neoadjuvant chemoradiation treatment. In current clinical practice, in patients with indication to adjuvant chemotherapy, closure of ileostomy is usually performed after the end of the treatment. However, a prolonged presence of the ostomy can induce the onset of ostomy-related complications such as stoma prolapse, parastomal hernia, mechanical ileus, high flow dehydration and damage to renal function. The ostomy-related complications may require unplanned or prolonged hospitalization, thus increasing costs.
Furthermore, the presence of the stoma may affect quality of life, causing alteration of the body image and imposing changes in the daily routine and lifestyle.
Early closure of the ileostomy in patients without signs of postoperative fistula has therefore been proposed.
Outcomes of early closure (within one month from surgery) of diverting ileostomy were demonstrated to be equal to those of late closure (more than 12 weeks from surgery) in 2 randomized trials. Early closure may favor a better quality of life for patients, shortening the life-period with ileostomy, reduces health system economic expenditure and may represent the most desirable and convenient choice. It was also associated with better long term functional results in a randomized trial.
In patients with indication to adjuvant therapy, however, timing to closure of the ostomy (before the start, during or at the end of treatment) is still a matter of debate in terms of compliance to systemic treatment, quality of life and overall costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patient treated with a curative resection for rectal cancer
- •Presence of a temporary ileostomy
- •Age >= 18 years
- •Indication to adjuvant treatment
- •Absence of anastomotic dehiscence (as proved by enema and/or endoscopy)
- •Able to give written informed consent
排除标准
- •ECOG Performance Status >=2
- •UICC stage IV
- •Severe and non-controlled systemic, oncologic, or infectious disease
研究组 & 干预措施
Delayed stoma closure
Ileostomy closure 15 days from the end of adjuvant therapy (up to 60 days)
干预措施: Timing of stoma closure (Other)
Early stoma closure
Ileostomy closure between 30 and 40 day after rectal resection
干预措施: Timing of stoma closure (Other)
结局指标
主要结局
Percentage of participants with good compliance to adjuvant therapy
时间窗: Measured within 48 hours after the end of the last cycle of adjuvant therapy
Composite outcome measure including timeliness and percentage of planned dose received. In each subject, treatment compliance is defined as good if both the following conditions are met: 1. adjuvant therapy starting date within 10 weeks of rectal resection; 2. total cumulative received dose (mg/m2) \>=70% of planned. The percentage of participants with good compliance in both arms will be compared.
次要结局
- Quality of life 1(At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization)
- Quality of life 3(At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization)
- Overall survival(Ut to 3 years from inclusion of the last patient)
- Bowel function(At 12 months from rectal resection)
- Costs analysis(At 12 months from randomization)
- Progression free survival(Ut to 3 years from inclusion of the last patient)
- Rate of stoma-related complications(All over the study duration (up to 12 months from randomization))
- Rate of chemotherapy side effects(Immediately after the end of every single cycle (each cycle duration varies from 5 to 14 days according to the chosen scheme))
- Quality of life 2(At baseline, at the end of cycle 3 (regardless of the cycle duration, that varies from 5 to 14 day according to local investigators choice) and at 12 months from randomization)
研究者
Paolo Massucco
MD
Ospedale Umberto I di Torino