Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy With 5-Fluorouracil and Oxaliplatin Versus 5-Fluorouracil Alone in Rectal Cancer
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ClinicalTrials.gov Identifier: NCT00349076 |
Recruitment Status :
Completed
First Posted : July 6, 2006
Last Update Posted : August 1, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rectal Neoplasms | Drug: 5-FU and oxaliplatin Drug: 5-FU | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1256 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | July 2006 |
Actual Primary Completion Date : | December 2015 |
Actual Study Completion Date : | June 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Preoperative simultaneous radiochemotherapy: 5-Fluorouracil und Oxaliplatin: Radiotherapy starts on day 1 of chemotherapy; 28 fractions; single dose: 1,8 Gy once per day, monday through friday; Total dose: 50,4 Gy; Oxaliplatin: 50 mg/m² i.v., days 1, 8, 22 und 29; 5-Fluorouracil: 250 mg/m²/d continuous infusion, days 1-14 and 22-35 Adjuvant Chemotherapy: Oxaliplatin: 100 mg/m² i.v. on day 1; Calciumfolinate: 400 mg/m² on day 1; 5-Fluorouracil: 2400 mg/m² continuous infusion for 46 hours; repeat day 15, 8 cycles |
Drug: 5-FU and oxaliplatin
Preoperative radiochemotherapy: Oxaliplatin: 50 mg/m² i.v., days 1, 8, 22 und 29; 5-Fluorouracil: 250 mg/m²/d continuous infusion, days 1-14 and 22-35 Adjuvant Chemotherapy: Oxaliplatin: 100 mg/m² i.v. on day 1; Calciumfolinate: 400 mg/m² on day 1; 5-Fluorouracil: 2400 mg/m² continuous infusion for 46 hours repeat day 15, 8 cycles |
Active Comparator: 2
Preoperative simultaneous radiochemotherapy: 5-Fluorouracil Radiotherapy starts on day 1 of chemotherapy; 28 fractions; single dose: 1,8 Gy once per day, monday through friday; Total dose: 50,4 Gy; 5-Fluorouracil: Days 1-5 and 29-33: 120h-continuous infusion 1000 mg/m²/d Adjuvant Chemotherapy: 5-Fluorouracil: 500 mg/m² on 5 consecutive days (day 1-5) i.v. bolus fot 2-5 minutes; repeat day 29, 4 cycles |
Drug: 5-FU
Preoperative radiochemotherapy: 5-Fluorouracil: Days 1-5 and 29-33: 120h-continuous infusion 1000 mg/m²/d Adjuvant Chemotherapy: 5-Fluorouracil: 500 mg/m² on 5 consecutive days (day 1-5) i.v. bolus fot 2-5 minutes; repeat day 29, 4 cycles |
- 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. [ Time Frame: 3 years ]
- Resection rate, rate of sphincter preservation, tumor regression, cumulative incidence of local and distant recurrences, overall survival, toxicity, quality of life [ Time Frame: 5-year follow up ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349076
Principal Investigator: | Rolf Sauer, M.D. | Dept. of Radiation Therapy, University of Erlangen, Germany |
Responsible Party: | University of Erlangen-Nürnberg Medical School |
ClinicalTrials.gov Identifier: | NCT00349076 |
Other Study ID Numbers: |
CAO/ARO/AIO-04 German Cancer Aid (no. 106759) |
First Posted: | July 6, 2006 Key Record Dates |
Last Update Posted: | August 1, 2016 |
Last Verified: | July 2016 |
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases |
Rectal Diseases Oxaliplatin Fluorouracil Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |