Description:

ODM derived from http://clinicaltrials.gov/show/NCT00349076

Link:

http://clinicaltrials.gov/show/NCT00349076

Keywords:
Versions (2) ▾
  1. 12/9/13
  2. 4/16/14
Uploaded on:

April 16, 2014

DOI:
No DOI assigned. To request one pleaselog in.
License:
Creative Commons BY 4.0
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Eligibility DRKS00003645 NCT00349076 Rectal Neoplasms

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 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 performance status finding <= 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 Criteria
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)