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
  Purpose

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


Condition Intervention Phase
Rectal Cancer
Drug: Capecitabine
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum

Resource links provided by NLM:


Further study details as provided by Austrian Breast & Colorectal Cancer Study Group:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 60
Study Start Date: October 2004
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm (radiochemotherapy)
single arm study (capecitabine, oxaliplatin)
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00297141

Locations
Austria
Hospital BHB St. Veit/Glan, Surgery
St. Veit a. d. Glan, Carinthia, Austria, 9330
Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria, 2700
Medical University of Graz, Oncology
Graz, Styria, Austria, 8036
State Hospital Leoben, Surgery
Leoben, Styria, Austria, 8700
Medical University of Innsbruck, Surgery
Innsbruck, Tyrol, Austria, 6020
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria, 4600
Paracelsus Medical University Salzburg - Oncology
Salzburg, Austria, 5020
Medical University of Vienna, Radiotherapy
Vienna, Austria, 1090
Sponsors and Collaborators
Austrian Breast & Colorectal Cancer Study Group
Sanofi-Synthelabo
Hoffmann-La Roche
Investigators
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
  More Information

No publications provided by Austrian Breast & Colorectal Cancer Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Austrian Breast & Colorectal Cancer Study Group
ClinicalTrials.gov Identifier: NCT00297141     History of Changes
Other Study ID Numbers: ABCSG 95 / TAKO 05, Studie R02 (95), 2004-002358-72
Study First Received: February 27, 2006
Last Updated: December 30, 2013
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Austrian Breast & Colorectal Cancer Study Group:
Preoperative
Radiochemotherapy
Newly Diagnosed
Primary Operable
Locally Advanced
Rectal Carcinoma
T3
Lower Rectum
Middle Rectum
ABCSG
TAKO
95
05

Additional relevant MeSH terms:
Carcinoma
Rectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Capecitabine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014