Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy With 5-Fluorouracil and Oxaliplatin Versus 5-Fluorouracil Alone in Rectal Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00349076
First received: July 5, 2006
Last updated: October 5, 2012
Last verified: October 2012
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Purpose
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 previous study (CAO/ARO/AIO-94, published in the New England Journal of Medicine 2004; 351:1731-40) this treatment results in only 6% of local failures, yet, still 36% of all patients develop distant metastasis. Therefore, our new study (CAO/ARO/AIO-04) incorporates new drugs, i.e. 5-FU + oxaliplatin, in an effort to improve the control of distant metastases. It is our hypothesis that the rate of disease free survival will improve by 5 to 8% after 3 years of follow-up.
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Neoplasms |
Drug: 5-FU and oxaliplatin Drug: 5-FU |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by University of Erlangen-Nürnberg Medical School:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 1200 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00349076
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| Germany | |
| Kreiskliniken Altötting-Burghausen | |
| Altötting, Germany, 84503 | |
| Gesundheitszentrum St. Marien | |
| Amberg, Germany, 92224 | |
| Onkologische Gemeinschaftspraxis | |
| Ansbach, Germany, 91522 | |
| Krankenhaus Marienwörth | |
| Bad Kreuznach, Germany, 55543 | |
| Caritas-Krankenhaus | |
| Bad Mergentheim, Germany, 97980 | |
| Onkologische Schwerpunktpraxis | |
| Bad Soden, Germany, 65812 | |
| Klinik Bad Trissl-Oberaudorf | |
| Bad Trissl, Germany, 83080 | |
| Klinikum Bayreuth GmbH | |
| Bayreuth, Germany, 95445 | |
| Aerzteforum Hennigsdorf | |
| Berlin, Germany, 16761 | |
| Städtische Kliniken | |
| Bielefeld, Germany, 33604 | |
| St.-Agnes-Hospital Bocholt | |
| Bocholt, Germany, 46397 | |
| St. Josef-Hospital | |
| Bochum, Germany, 44791 | |
| Ruhr-Universität Bochum; Knappschaftskrankenhaus | |
| Bochum, Germany, 44892 | |
| Klinikum Bremen-Mitte | |
| Bremen, Germany, 28205 | |
| Onkologische Praxis | |
| Buchholz, Germany, 21244 | |
| Praxis für Hämatologie und Onkologie | |
| Burgwedel, Germany, 30938 | |
| Klinikum Coburg gGmbH | |
| Coburg, Germany, 96450 | |
| Onkologisches Versorgungszentrum Rehling-Donauwörth-Dachau | |
| Donauwörth, Germany, 86609 | |
| Universitätsklinikum Carl Gustav Carus | |
| Dresden, Germany, 01307 | |
| Katholisches Krankenhaus St. Nepomuk | |
| Erfurt, Germany, 99097 | |
| Dept. of Radiation Therapy, University of Erlangen | |
| Erlangen, Germany, 91054 | |
| Alfried Krupp Krankenhaus | |
| Essen, Germany, 45131 | |
| Universitätsklinikum Essen | |
| Essen, Germany, 45122 | |
| Klinikum Esslingen a.N. | |
| Esslingen, Germany, 73073 | |
| Universitätsklinikum | |
| Frankfurt/Main, Germany, 60590 | |
| Universitätsklinikum Freiburg | |
| Freiburg, Germany, 79110 | |
| Weisseritztal-Kliniken | |
| Freital, Germany, 01705 | |
| Kliniken an der Paar, Krankenhaus Friedberg | |
| Friedberg, Germany, 86316 | |
| Klinikum Fulda | |
| Fulda, Germany, 36013 | |
| SRH-Waldklinikum | |
| Gera, Germany, 07548 | |
| Wilhelm-Anton-Hospital | |
| Goch, Germany, 47574 | |
| Universitätsklinikum Greifswald | |
| Greifswald, Germany, 17475 | |
| Klinik am Eichert | |
| Göppingen, Germany, 73035 | |
| Georg-August-Universität Göttingen | |
| Göttingen, Germany, 37075 | |
| St. Elisabeth und St. Barbara Krankenhaus | |
| Halle, Germany, 06110 | |
| Diakonie Klinikum Hamburg | |
| Hamburg, Germany, 22527 | |
| Asklepios Klinik Hamburg-Harburg | |
| Hamburg, Germany, 21075 | |
| Praxis für Hämatologie und Onkologie, Hamm | |
| Hamm, Germany, 59071 | |
| Marienhospital | |
| Herne, Germany, 44625 | |
| Onkologische Schwerpunktpraxis | |
| Hildesheim, Germany, 31134 | |
| Universitätsklinikum des Saarlandes | |
| Homburg/Saar, Germany, 66421 | |
| Klinik für Knochenmarkstransplantation und Hämatologie/Onkologie GmbH | |
| Idar-Oberstein, Germany, 55743 | |
| Klinikum der Friedrich Schiller Universität | |
| Jena, Germany, 07740 | |
| Innere Medizin, Hämatologie und Int. Onkologie | |
| Kassel, Germany, 34117 | |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | |
| Kiel, Germany, 24015 | |
| Onkologische Schwerpunktpraxis | |
| Kronach, Germany, 96317 | |
| Gemeinschaftspraxis für Hämatologie und Internistische Onkologie | |
| Köln, Germany, 51105 | |
| Praxis für Hämatologie und Onkologie | |
| Köln, Germany, 50677 | |
| Klinikum Landshut | |
| Landshut, Germany, 84034 | |
| Gemeinschaftspraxis Onkologie | |
| Landshut, Germany, 84028 | |
| Universitätsklinikum Leipzig | |
| Leipzig, Germany, 04103 | |
| Universitätsklinikum Schleswig-Holstein, Campus Lübeck | |
| Lübeck, Germany, 23538 | |
| Universitätsklinikum - St. Hildegardis-Krankenhaus Mainz | |
| Mainz, Germany, 65131 | |
| Phillips-Universität Marburg | |
| Marburg, Germany, 35043 | |
| Gemeinschaftspraxis Onkologie | |
| Muhr am See, Germany, 91735 | |
| Klinikum Schwäbisch Gmünd, Stauferklinik | |
| Mutlangen, Germany, 73557 | |
| Kliniken Maria Hilf | |
| Mönchengladbach, Germany, 41061 | |
| Klinikum rechts der Isar, Technische Universität | |
| München, Germany, 81675 | |
| Universitätsklinikum Großhadern | |
| München, Germany, 81377 | |
| Clemenshospital Münster | |
| Münster, Germany, 48149 | |
| Universitätsklinikum Münster | |
| Münster, Germany, 48149 | |
| Hämatologisch-onkologische Schwerpunktpraxis Northeim | |
| Northeim, Germany, 37154 | |
| Klinikum Nürnberg | |
| Nürnberg, Germany, 90419 | |
| Darmzentrum Ortenau | |
| Offenburg, Germany, 77654 | |
| Klinikum Oldenburg; Pius Hospital Oldenburg | |
| Oldenburg, Germany, 26133 | |
| Paracelsus-Krankenhaus Ruit | |
| Ostfildern, Germany, 73760 | |
| St. Vincenz Krankenhaus | |
| Paderborn, Germany, 33098 | |
| Klinikum Passau | |
| Passau, Germany, 94032 | |
| St. Josefs Krankenhaus | |
| Potsdam, Germany, 14471 | |
| Universitätsklinikum Regensburg | |
| Regensburg, Germany, 93042 | |
| Krankenhaus Barmherzige Brüder | |
| Regensburg, Germany, 93049 | |
| Schwerpunktpraxis für Hämatologie und Onkologie mit Tagesklinik | |
| Regensburg, Germany, 93047 | |
| Klinikum Rosenheim | |
| Rosenheim, Germany, 83022 | |
| Medizinische Fakultät der Universität Rostock | |
| Rostock, Germany, 18059 | |
| Kreiskrankenhaus Rottweil | |
| Rottweil, Germany, 78628 | |
| Thüringen-Kliniken Saalfeld-Rudolstadt | |
| Saalfeld, Germany, 07318 | |
| Hämatologisch-Onkologische Schwerpunktpraxis | |
| Singen, Germany, 78224 | |
| Onkologische Praxisgemeinschaft Stade | |
| Stade, Germany, 21680 | |
| Klinikum Traunstein | |
| Traunstein, Germany, 83278 | |
| Onkologische Schwerpunktpraxis Traunstein | |
| Traunstein, Germany, 83278 | |
| Krankenhaus der Barmherzigen Brüder | |
| Trier, Germany, 54292 | |
| Universitätsklinikum Ulm | |
| Ulm, Germany, 89081 | |
| Marienhaus Klinikum, St. Elisabeth Klinik Saarlouis, St. Michael Krankenhaus Völklingen | |
| Völklingen, Germany, 66333 | |
| Klinikum Wetzlar-Braunfels | |
| Wetzlar, Germany, 35578 | |
| Asklepios Paulinen Klinik | |
| Wiesbaden, Germany, 65197 | |
| Reinhard-Nieter-Krankenhaus | |
| Wilhelmshaven, Germany, 26389 | |
| Juliusspital | |
| Wuerzburg, Germany, 97070 | |
| Missionsärztliche Klinik | |
| Würzburg, Germany, 97074 | |
| Universitätsklinikum Würzburg | |
| Würzburg, Germany, 97080 | |
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
| Principal Investigator: | Rolf Sauer, M.D. | Dept. of Radiation Therapy, University of Erlangen, Germany |
More Information
No publications provided by University of Erlangen-Nürnberg Medical School
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Erlangen-Nürnberg Medical School |
| ClinicalTrials.gov Identifier: | NCT00349076 History of Changes |
| Other Study ID Numbers: | CAO/ARO/AIO-04, German Cancer Aid (no. 106759) |
| Study First Received: | July 5, 2006 |
| Last Updated: | October 5, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Adjuvants, Immunologic |
Fluorouracil Oxaliplatin Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents |
ClinicalTrials.gov processed this record on May 19, 2013