Status:
COMPLETED
Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy With 5-Fluorouracil and Oxaliplatin Versus 5-Fluorouracil Alone in Rectal Cancer
Lead Sponsor:
University of Erlangen-Nürnberg Medical School
Conditions:
Rectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Standard treatment for locally advanced cancer of the rectum is preoperative chemoradiotherapy with 5-Fluorouracil (5-FU) plus 4 cycles of postoperative chemotherapy with 5-FU. According to our previo...
Eligibility Criteria
Inclusion
- Minimum age: 18 years
- Histologically proven, advanced primary carcinoma of the rectum (tumor ? 12cm from the anal verge, with clinically staged T3/4 or any node-positive disease
- No prior therapy except a diverting stoma
- ECOG PS less than or equal 2
- 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
- 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
- Written informed consent before randomization
Exclusion
- Pregnant or breast feeding women
- Fertile patients without adequate contraception during therapy
- Past or ongoing drug abuse or alcoholic excess
- Prior chemotherapy
- Prior radiotherapy to the pelvis
- Prior (within 4 weeks) or concurrent treatment with any other investigational agent
- Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- 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
- Peripheral neuropathy \> 2 (NCI CTC AE grading)
- 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 discussed with the principal investigator
- Chronic diarrhea (\> NCI CTC AE-Grad 1)
- Known allergy to substances containing platinum compounds
- Concurrent use of the antiviral agent sorivudine or chemically related analogues
- Known deficiency of dehydropyrimidindehydrogenase (DPD)
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
1256 Patients enrolled
Trial Details
Trial ID
NCT00349076
Start Date
July 1 2006
End Date
June 1 2016
Last Update
August 1 2016
Active Locations (89)
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1
Kreiskliniken Altötting-Burghausen
Altötting, Germany, 84503
2
Gesundheitszentrum St. Marien
Amberg, Germany, 92224
3
Onkologische Gemeinschaftspraxis
Ansbach, Germany, 91522
4
Krankenhaus Marienwörth
Bad Kreuznach, Germany, 55543