Treatment of patients with locally advanced rectal cancer. TEGAFOX (UFT/leukovorin og Oxaliplatin) before, during and after curatively intended radiotherapy. A Danish phase I/II trial - TEGAFOX

Odense University Hospital0 个研究点目标入组 60 人开始时间: 2004年8月18日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•- Histologically proven adenocarcinoma of the rectum
•- Locally advanced (surgically unresectable) or recurrent rectal cancer
•- Primarily unresectable: fixation of tumor to sacral bone or pelvic wall or invation into pelvic soft tissue (e.g. nerves, blood vessels, bladder, prostate)
•- WHO perforamnce 0-2
•- Disease confined to the pelvis
•- A life expectancy of at least 3 months
•- Age >18 years
•-Adequate hematological (White Blood Cell counts (WBC) =3.0 x 109/l and platelets =100 x 109/l), hepatic (bilirubin <1.5 x upper normal limit) and renal (creatinine <150 umol/l) function
•- Written and oral informed consent of the patient in accordance with the Ethical Committees
•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

•- Adjuvant chemotherapy or immunotherapy within 12 months
•- Previous RT to the pelvic area
•- Exploratory laparotomy within 4 weeks
•- Patients with any contraindication to the planned chemotherapy or RT
•- Other active malignant disease within 5 years except adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix
•- Other experimental theapy while treated according to this study

发起方