Prospective randomised multicenter phase-III-study:Preoperative radiochemotherapy and adjuvant chemotherapy with 5-Fluorouracil plus oxaliplatin versus preoperative radiochemotherapy and adjuvant chemotherapy with 5-Fluorouracil for locally advanced rectal cancer - CAO/ARO/AIO-04

Phase 1

Conditions: Male or femal patients suffering from histologically proven carcinoma of the rectum (tumor = 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease
MedDRA version: 8.1Level: HLTClassification code 10038039Term: Rectal neoplasms malignant

Registration Number: EUCTR2006-002385-20-DE

Lead Sponsor: Strahlenklinik, Universitätsklinikum Erlangen, insoweit handelnd für den Freistaat Bayern

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1200

Inclusion Criteria

1. Age = 18 years
2. Histologically proven, advanced primary carcinoma of the rectum (tumor = 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease
3. No prior therapy except a diverting stoma
4. ECOG PS = 2
5. Adequate bone marrow function:
Leukocytes > 3,5 x 10^9/L
Absolute neutrophil count > 1,5 x 10^9/L
Platelet count > 100 x 10^9/L
Hemoglobin > 10 g/dl
6. Adequate hepatic function:
Total bilirubin < 2,0 mg/dl
ALAT, ASAT, alkaline phosphatase, gamma-GT < 3 x ULN
7. Serum creatinine < 1,5 mg/dl, creatinine-clearance > 50 ml/min
8. Written informed consent before randomization

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

1. Pregnant or breast feeding women
2. Fertile patients without adaequate contraception during therapy
3. Past or ongoing drug abuse or alcoholic excess
4. Prior chemotherapy
5. Prior radiotherapy to the pelvis
6. Prior (within 4 weeks) or concurrent treatment with any other investigational agent
8. Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
9. History of severe somatic or psychological diseases:
- instable cardiac disease not well controlled with medication, myocardial infarction within the last 6 months
- Central nervous system disorders or psychiatric disability including dementia or epileptic disease
- active uncontrolled intercurrent infections or sepsis
10. Peripheral neuropathy = 2 (NCI CTC AE grading)
11. Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. The inclusion of patients with other adequately treated tumors within the last 5 years has to be dicussed with the principal investigator
12. Chronic diarrhea (> NCI CTC AE-Grad 1)
13. Known allergy to substances containing platinum compounds
14. Concurrent use of the antiviral agent sorivudine or chemically related analogues
15. Known deficiency of dehydropyrimidindehydrogenase (DPD)