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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Rectal Neoplasms

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Trial Information

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


Inclusion Criteria:



- 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 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival at 3 years defined as the interval from randomization to locoregional or metastatic recurrence or the appearance or a secondary colorectal cancer or death, whichever occurs first.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Rolf Sauer, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. of Radiation Therapy, University of Erlangen, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CAO/ARO/AIO-04

NCT ID:

NCT00349076

Start Date:

July 2006

Completion Date:

December 2015

Related Keywords:

  • Rectal Neoplasms
  • Neoplasms
  • Rectal Neoplasms

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