NCT01674309已完成2 期
Phase II: First Line Treatment by FOLFIRINOX for Patients With a Rectum Cancer With Synchronous Non Resectable Metastasis
Federation Francophone de Cancerologie Digestive29 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 29
- 主要终点
- Tumor control rate of the primary tumor and metastasis
研究概览
简要总结
The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer, with an objective response rate of about 70 %. This phase II is to investigate if this systematic attack chemotherapy could control at the same time the rectal tumor and the synchronous metastasis without compromising secondarily the tumor or the metastasis resection or a radiochemotherapy administration.
- The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1).
- The secondary objectives are:
- safety of the treament,
- rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation),
- survival without local failure (radiological or clinical progression of the rectal cancer or local complication),
- rectal tumor response rate (CT scan, MRI and endocopy),
- metastasis response rate,
- disease free survival after complete resection (of primitive tumor and metastases),
- progression free survival (local or distal),
- overall survival, quality of life (QLQ-C30 + CR 29).
详细描述
The FOLFIRINOX protocol seems a promising protocol as attack treatment of a rectum cancer, with an objective response rate of about 70 %. This phase II is to investigate if this systematic attack chemotherapy could control at the same time the rectal tumor and the synchronous metastasis without compromising secondarily the tumor or the metastasis resection or a radiochemotherapy administration.
- The main objective of the trial is to investigate the tumoral control rate at 4 months, according to the RECIST criteria (version 1.1).
- The secondary objectives are:
- safety of the treament,
- rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation),
- survival without local failure (radiological or clinical progression of the rectal cancer or local complication),
- rectal tumor response rate (CT scan, MRI and endocopy),
- metastasis response rate,
- disease free survival after complete resection (of primitive tumor and metastases),
- progression free survival (local or distal),
- overall survival, quality of life (QLQ-C30 + CR 29).
- Inclusion and non inclusion criteria
- Treatment
- Follow up
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically proven adenocarcinoma of the rectum, the lower pole less than 15 cm from the anal verge
- •Patient should not have receive any treatment for cancer
- •Synchronous metastases with unresectable hepatic and/or lung localization or uncertain resectability (potentially resectable)
- •Measurable lesions by RECIST 1.1 (metastasis and primary cancer of the rectum)
- •Age ≥ 18 years
- •ANC ≥ 1.5 x 10 9/L, platelets ≥ 100 x 10 9/L, creatinine clearance ≥ 60 mL/min
- •Hemoglobin ≥ 10 g /dL
- •Signed informed consent
排除标准
- •Rectal Cancer in occlusion requiring surgery or a prosthesis in emergency
- •Rectal bleeding severe and active
- •Prior pelvic irradiation
- •History of cancer, except non-melanoma skin cancer, carcinoma in situ of the cervix treated curatively and other cancers treated curatively if they do not relapse over 3 years,
- •Hepatic impairment (total bilirubin> 1.5 x upper limit of normal (ULN) and serum albumin <25g / L); known Gilbert's disease
- •Uncontrolled severe infection,
- •Severe pain (VAS> 5/10) uncontrollable by opioid therapy
- •Symptomatic sensorimotor peripheral neuropathy
- •Pregnant or lactating patients or patient of both sexes with childbearing potential and not using adequate contraception method
- •Patient receiving or having received an experimental therapy within 4 weeks prior to enter into the study or participating in another clinical study of other experimental drugs
- •Known hypersensitivity to any component of the treatment
研究组 & 干预措施
single arm study/ non randomized trial
Other
FOLFORINOX
干预措施: FOLFORINOX (Drug)
结局指标
主要结局
Tumor control rate of the primary tumor and metastasis
时间窗: 4 months
The tumor control rate of the primary site and metastasis is defined as Complete response or Partial response or stability according to RECIST 1.1 criteria
次要结局
- metastasis response rate(4 months)
- rectal tumor response rate (CT scan, MRI and endocopy)(4 months)
- Toxicity of the treatment(Up to 4 months after Last Patient First Visit)
- survival without local failure (radiological or clinical progression of the rectal cancer or local complication)(Up to 4 months after Last Patient First Visit)
- rate of local failure and local complication (occlusion, important bleedings, resistant pains with morphinic treatment, perforation)(4 months)
研究者
研究点 (29)
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