Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

February 27, 2006

Last Updated Date

January 19, 2007

Start Date ^†

October 2004

Current Primary Outcome Measures ^†

Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00297141 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma

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

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

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Rectal Cancer

Intervention ^†

Drug: Capecitabine
Drug: Oxaliplatin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

March 2006

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Austria

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00297141

Responsible Party

Secondary IDs ^††

Studie 95, EudraCT: 2004-002358-72

Study Sponsor ^†

Austrian Breast & Colorectal Cancer Study Group

Collaborators ^††

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

Information Provided By

Austrian Breast & Colorectal Cancer Study Group

Verification Date

February 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.