Home
Search
Study Topics
Glossary
|
|
|
|
|
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 † |
|
||||||||||||
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 † | 60 | ||||||||||||
Completion Date | March 2006 | ||||||||||||
Primary Completion Date | |||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||
Gender | Both | ||||||||||||
Ages | 18 Years to 80 Years | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
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 †† |
|
||||||||||||
Investigators † |
|
||||||||||||
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. |