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Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy With 5-Fluorouracil and Oxaliplatin Versus 5-Fluorouracil Alone in Rectal Cancer

Information source: University of Erlangen-NŘrnberg Medical School
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rectal Neoplasms

Intervention: 5-FU and oxaliplatin (Drug); 5-FU (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University of Erlangen-NŘrnberg Medical School

Official(s) and/or principal investigator(s):
Rolf Sauer, M.D., Principal Investigator, Affiliation: Dept. of Radiation Therapy, University of Erlangen, Germany

Summary

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.

Clinical Details

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

Primary outcome: 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.

Secondary outcome: Resection rate, rate of sphincter preservation, tumor regression, cumulative incidence of local and distant recurrences, overall survival, toxicity, quality of life

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

Kreiskliniken Alt├Âtting-Burghausen, Alt├Âtting 84503, Germany

Gesundheitszentrum St. Marien, Amberg 92224, Germany

Onkologische Gemeinschaftspraxis, Ansbach 91522, Germany

Krankenhaus Marienw├Ârth, Bad Kreuznach 55543, Germany

Caritas-Krankenhaus, Bad Mergentheim 97980, Germany

Onkologische Schwerpunktpraxis, Bad Soden 65812, Germany

Klinik Bad Trissl-Oberaudorf, Bad Trissl 83080, Germany

Klinikum Bayreuth GmbH, Bayreuth 95445, Germany

Aerzteforum Hennigsdorf, Berlin 16761, Germany

St├Ądtische Kliniken, Bielefeld 33604, Germany

St.-Agnes-Hospital Bocholt, Bocholt 46397, Germany

Ruhr-Universit├Ąt Bochum; Knappschaftskrankenhaus, Bochum 44892, Germany

St. Josef-Hospital, Bochum 44791, Germany

Klinikum Bremen-Mitte, Bremen 28205, Germany

Onkologische Praxis, Buchholz 21244, Germany

Praxis f├╝r H├Ąmatologie und Onkologie, Burgwedel 30938, Germany

Klinikum Coburg gGmbH, Coburg 96450, Germany

Onkologisches Versorgungszentrum Rehling-Donauw├Ârth-Dachau, Donauw├Ârth 86609, Germany

Universit├Ątsklinikum Carl Gustav Carus, Dresden 01307, Germany

Katholisches Krankenhaus St. Nepomuk, Erfurt 99097, Germany

Dept. of Radiation Therapy, University of Erlangen, Erlangen 91054, Germany

Alfried Krupp Krankenhaus, Essen 45131, Germany

Universit├Ątsklinikum Essen, Essen 45122, Germany

Klinikum Esslingen a.N., Esslingen 73073, Germany

Universit├Ątsklinikum, Frankfurt/Main 60590, Germany

Universit├Ątsklinikum Freiburg, Freiburg 79110, Germany

Weisseritztal-Kliniken, Freital 01705, Germany

Kliniken an der Paar, Krankenhaus Friedberg, Friedberg 86316, Germany

Klinikum Fulda, Fulda 36013, Germany

SRH-Waldklinikum, Gera 07548, Germany

Wilhelm-Anton-Hospital, Goch 47574, Germany

Universit├Ątsklinikum Greifswald, Greifswald 17475, Germany

Klinik am Eichert, G├Âppingen 73035, Germany

Georg-August-Universit├Ąt G├Âttingen, G├Âttingen 37075, Germany

St. Elisabeth und St. Barbara Krankenhaus, Halle 06110, Germany

Asklepios Klinik Hamburg-Harburg, Hamburg 21075, Germany

Diakonie Klinikum Hamburg, Hamburg 22527, Germany

Praxis f├╝r H├Ąmatologie und Onkologie, Hamm, Hamm 59071, Germany

Marienhospital, Herne 44625, Germany

Onkologische Schwerpunktpraxis, Hildesheim 31134, Germany

Universit├Ątsklinikum des Saarlandes, Homburg/Saar 66421, Germany

Klinik f├╝r Knochenmarkstransplantation und H├Ąmatologie/Onkologie GmbH, Idar-Oberstein 55743, Germany

Klinikum der Friedrich Schiller Universit├Ąt, Jena 07740, Germany

Innere Medizin, H├Ąmatologie und Int. Onkologie, Kassel 34117, Germany

Universit├Ątsklinikum Schleswig-Holstein, Campus Kiel, Kiel 24015, Germany

Onkologische Schwerpunktpraxis, Kronach 96317, Germany

Gemeinschaftspraxis f├╝r H├Ąmatologie und Internistische Onkologie, K├Âln 51105, Germany

Praxis f├╝r H├Ąmatologie und Onkologie, K├Âln 50677, Germany

Gemeinschaftspraxis Onkologie, Landshut 84028, Germany

Klinikum Landshut, Landshut 84034, Germany

Universit├Ątsklinikum Leipzig, Leipzig 04103, Germany

Universit├Ątsklinikum Schleswig-Holstein, Campus L├╝beck, L├╝beck 23538, Germany

Universit├Ątsklinikum - St. Hildegardis-Krankenhaus Mainz, Mainz 65131, Germany

Phillips-Universit├Ąt Marburg, Marburg 35043, Germany

Gemeinschaftspraxis Onkologie, Muhr am See 91735, Germany

Klinikum Schw├Ąbisch Gm├╝nd, Stauferklinik, Mutlangen 73557, Germany

Kliniken Maria Hilf, M├Ânchengladbach 41061, Germany

Klinikum rechts der Isar, Technische Universit├Ąt, M├╝nchen 81675, Germany

Universit├Ątsklinikum Gro├čhadern, M├╝nchen 81377, Germany

Clemenshospital M├╝nster, M├╝nster 48149, Germany

Universit├Ątsklinikum M├╝nster, M├╝nster 48149, Germany

H├Ąmatologisch-onkologische Schwerpunktpraxis Northeim, Northeim 37154, Germany

Klinikum N├╝rnberg, N├╝rnberg 90419, Germany

Darmzentrum Ortenau, Offenburg 77654, Germany

Klinikum Oldenburg; Pius Hospital Oldenburg, Oldenburg 26133, Germany

Paracelsus-Krankenhaus Ruit, Ostfildern 73760, Germany

St. Vincenz Krankenhaus, Paderborn 33098, Germany

Klinikum Passau, Passau 94032, Germany

St. Josefs Krankenhaus, Potsdam 14471, Germany

Krankenhaus Barmherzige Br├╝der, Regensburg 93049, Germany

Schwerpunktpraxis f├╝r H├Ąmatologie und Onkologie mit Tagesklinik, Regensburg 93047, Germany

Universit├Ątsklinikum Regensburg, Regensburg 93042, Germany

Klinikum Rosenheim, Rosenheim 83022, Germany

Medizinische Fakult├Ąt der Universit├Ąt Rostock, Rostock 18059, Germany

Kreiskrankenhaus Rottweil, Rottweil 78628, Germany

Th├╝ringen-Kliniken Saalfeld-Rudolstadt, Saalfeld 07318, Germany

H├Ąmatologisch-Onkologische Schwerpunktpraxis, Singen 78224, Germany

Onkologische Praxisgemeinschaft Stade, Stade 21680, Germany

Klinikum Traunstein, Traunstein 83278, Germany

Onkologische Schwerpunktpraxis Traunstein, Traunstein 83278, Germany

Krankenhaus der Barmherzigen Br├╝der, Trier 54292, Germany

Universit├Ątsklinikum Ulm, Ulm 89081, Germany

Marienhaus Klinikum, St. Elisabeth Klinik Saarlouis, St. Michael Krankenhaus V├Âlklingen, V├Âlklingen 66333, Germany

Klinikum Wetzlar-Braunfels, Wetzlar 35578, Germany

Asklepios Paulinen Klinik, Wiesbaden 65197, Germany

Reinhard-Nieter-Krankenhaus, Wilhelmshaven 26389, Germany

Juliusspital, Wuerzburg 97070, Germany

Missions├Ąrztliche Klinik, W├╝rzburg 97074, Germany

Universit├Ątsklinikum W├╝rzburg, W├╝rzburg 97080, Germany

Additional Information

Starting date: July 2006
Last updated: March 5, 2015

Page last updated: August 20, 2015

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