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

• Conditions: ocally advanced non-resectable rectal cancer; MedDRA version: 6.0Level: LLTClassification code 10038050

• Registration Number: EUCTR2004-001347-29-DK
• Lead Sponsor: Odense University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- 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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess toxicity and feasibility of TEGAFOX followed by radiochemotherapy (UFT + oxaliplatin) in patients with LARC;Secondary Objective: The number of patients achieving complete pathological response (pCR)<br>Survival;Primary end point(s): Phase I<br>Toxicity and feasibility<br>Phase II<br>Number of patients achieving complete pathological response (pCR)<br>Survival