eoadjuvant radiotherapy combined with capecitabine and sorafenib in patients with advanced, K-ras mutated rectal cancer. A randomized multicenter phase I/II trial.

SAKK (Swiss Group for Clinical Cancer Research)0 个研究点目标入组 47 人开始时间: 2010年12月6日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Histologically confirmed advanced adenocarcinoma of the rectum with or without nodal involvement requiring surgery, stage mrT 3/4 and/or mrN 1-2 cM0.
•- Tumors with the K-ras gene mutation
•- Patient is considered operable
•- Age >= 18 years
•- Adequate hematological values
•- Adequate renal and hepatic function
•- PT-INR <= 1.5 or PTT <= 1.5 x ULN
•- Women are not breastfeeding, are using contraception if sexually active, are not pregnant
•- Men agree not to father a child
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- Previous malignancy within 5 years (with exception of adequately treated cervical carcinoma or localized non-melanoma skin cancer)
•- Distant metastasis
•- Concurrent treatment with other experimental drugs or other anti-cancer therapy
•- Any prior treatment for rectal cancer
•- Patients with evidence or history of bleeding diathesis
•- Uncontrolled hypertension
•- Organ allografts
•- Any concomitant drugs contraindicated for use with the trial drugs

发起方

SAKK (Swiss Group for Clinical Cancer Research)