Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

NCT00297141 | Completed Phase 2

• 3 other identifiers: ABCSG 95 / TAKO 05Studie R02 (95)2004-002358-72
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 8

Brief Summary

Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme

Conditions

Rectal Cancer

Keywords

Preoperative; Radiochemotherapy; Newly Diagnosed; Primary Operable; Locally Advanced; Rectal Carcinoma; T3; Lower Rectum; Middle Rectum; ABCSG; TAKO; 95; 05

Outcome Measures

Primary Outcomes (1)

• Rate of T-downstaging (Reduction of the T-stadium)

  surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)

  at the time of final surgery

Secondary Outcomes (1)

• Evaluation of the toxicity grade III and IV of the therapy scheme

  week 1 to max. week 10

Study Arms (1)

single arm (radiochemotherapy)

EXPERIMENTAL

single arm study (capecitabine, oxaliplatin)

Drug: Capecitabine; Drug: Oxaliplatin

Interventions

Capecitabine DRUG

chemotherapy oral use

Also known as: Xeloda, RO 09-1978

single arm (radiochemotherapy)

Oxaliplatin DRUG

chemotherapy intravenous use

Also known as: treatment defined only by active substance, (no trade name defined; investigators choice)

single arm (radiochemotherapy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 - 80
• Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge)
• According to MRI tumor extensions into the perirectal fat tissue (cT3)
• No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma
• WHO performance status 0 - 2
• Adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not more than 100.000/ml)
• Adequate hepatic function (bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN)
• Adequate renal function (creatinin - not more than 1.5 mg/dl)
• Willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (for example birth-control pill, loop, condom) during and at least 3 month after closure of the study
• Life expectancy of at least 3 month
• Signed written Informed Consent before recruitment

You may not qualify if:

• Former radio- and/or chemotherapy
• Tumor of the upper rectum
• Any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma)
• Peripheral Neuropathy (NCI CTC - not higher than Grade 1)
• General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine
• Any other untreated not malign diseases: Cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric disorders
• Florid, serious infection at the time of recruitment
• Legally limited capacity or evidence of a neurological or psychiatric disease, the investigator is the opinion it will constrict the patients compliance
• Evidence of lacking willingness for cooperation of the patient
• Pregnant or breast feeding women

Sponsors & Collaborators

• Austrian Breast & Colorectal Cancer Study Group: lead
• Sanofi-Synthelabo: collaborator
• Hoffmann-La Roche: collaborator

Study Sites (8)

Hospital BHB St. Veit/Glan, Surgery

Saint Veit A. D. Glan, Carinthia, 9330, Austria

Location

Hospital Wiener Neustadt

Wiener Neustadt, Lower Austria, 2700, Austria

Location

Paracelsus Medical University Salzburg - Oncology

Salzburg, Salzburg, 5020, Austria

Location

Medical University of Graz, Oncology

Graz, Styria, 8036, Austria

Location

State Hospital Leoben, Surgery

Leoben, Styria, 8700, Austria

Location

Medical University of Innsbruck, Surgery

Innsbruck, Tyrol, 6020, Austria

Location

Klinikum Wels-Grieskirchen GmbH

Wels, Upper Austria, 4600, Austria

Location

Medical University of Vienna, Radiotherapy

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

• Ofner D, Devries AF, Schaberl-Moser R, Greil R, Rabl H, Tschmelitsch J, Zitt M, Kapp KS, Fastner G, Keil F, Eisterer W, Jager R, Offner F, Gnant M, Thaler J; TAKO 05/ABCSG R-02 Trial Investigators. Preoperative oxaliplatin, capecitabine, and external beam radiotherapy in patients with newly diagnosed, primary operable, cT(3)NxM0, low rectal cancer: a phase II study. Strahlenther Onkol. 2011 Feb;187(2):100-7. doi: 10.1007/s00066-010-2182-6. Epub 2011 Jan 21.

  PMID: 21267531 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Dietmar Oefner, MD

  Austrian Breast & Colorectal Cancer Study Group

  PRINCIPAL INVESTIGATOR

• Alexander de Vries, MD

  Austrian Breast & Colorectal Cancer Study Group

  PRINCIPAL INVESTIGATOR

• Josef Thaler, MD

  Austrian Breast & Colorectal Cancer Study Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2006
• First Posted: February 28, 2006
• Study Start: October 1, 2004
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 31, 2013

Record last verified: 2013-12

Locations

AU (8)