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Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Sanofi-Synthelabo
Hoffmann-La Roche
Information provided by (Responsible Party):
Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00297141
First received: February 27, 2006
Last updated: December 30, 2013
Last verified: December 2013

February 27, 2006
December 30, 2013
October 2004
December 2013   (final data collection date for primary outcome measure)
Rate of T-downstaging (Reduction of the T-stadium) [ Time Frame: at the time of final surgery ] [ Designated as safety issue: No ]
surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)
Complete list of historical versions of study NCT00297141 on ClinicalTrials.gov Archive Site
Evaluation of the toxicity grade III and IV of the therapy scheme [ Time Frame: week 1 to max. week 10 ] [ Designated as safety issue: Yes ]
from Visit 1 till surgery: weekly visits (visit 1 to visit 5) followed by final examination (performed 1 to 2 weeks after visit 5) before surgery followed by hospital admission (performed 1 to 2 weeks after final examination) followed by surgery ((performed 1 to 2 weeks after hospital admission)
Evaluation of the toxicity grade III and IV of the therapy scheme
Not Provided
Not Provided
 
Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma
Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum

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

About 60 patients with locally advanced rectal carcinoma (cT3, Nx, M0) of the lower and middle rectum will be recruited.

The radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). Probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
  • Drug: Capecitabine
    chemotherapy oral use
    Other Names:
    • Xeloda
    • RO 09-1978
  • Drug: Oxaliplatin
    chemotherapy intravenous use
    Other Names:
    • treatment defined only by active substance
    • (no trade name defined; investigators choice)
Experimental: single arm (radiochemotherapy)
single arm study (capecitabine, oxaliplatin)
Interventions:
  • Drug: Capecitabine
  • Drug: Oxaliplatin
Ofner D, Devries AF, Schaberl-Moser R, Greil R, Rabl H, Tschmelitsch J, Zitt M, Kapp KS, Fastner G, Keil F, Eisterer W, Jäger 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, cT₃NxM0, 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)
  • Women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test)
  • 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
  • Exclusion of distant metastases at the time of recruitment

Exclusion Criteria:

  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00297141
ABCSG 95 / TAKO 05, Studie R02 (95), 2004-002358-72
No
Austrian Breast & Colorectal Cancer Study Group
Austrian Breast & Colorectal Cancer Study Group
  • Sanofi-Synthelabo
  • Hoffmann-La Roche
Principal Investigator: 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
Austrian Breast & Colorectal Cancer Study Group
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP