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: 8.1 Level: HLT Classification code 10038039 Term: Rectal neoplasms malignant
Conditions
Interventions
Product Name: Oxaliplatin
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Oxaliplatin
CAS Number: 61825-94-3
Product Name: 5-Fluorouracil
Pharmaceutical Form: Solution for
Sponsors
Strahlenklinik, Universitätsklinikum Erlangen, insoweit handelnd für den Freistaat Bayern
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether the addition of oxaliplatin to preoperative fluoropyrimidine-based chemoradiation and postoperative fluoropyrimidine-based chemotherapy improves disease-free survival in locally advances rectal cancer (UICC stage II and III);Secondary Objective: • Resectionrate (R0, R1, R2) • Rate of sphincter preservation • Tumorregression • Cumulative incidence of local and distant recurrences • Overall survival • Akute and long-term toxicity • Quality of life ;Primary end point(s): Disease free survival at 3 years defined as the interval from randomization to locoregional or metastatic recurrence or the appearance of a secondary colorectal cancer or death, whichever occurs first. | — |
Countries
Germany
Outcome results
None listed