Neoadjuvant Radiation Therapy and Capecitabine in Treating Patients With Stage III or Stage IV Colorectal Adenocarcinoma
Recruitment status was: Active, not recruiting
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as capecitabine, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant radiation therapy and capecitabine work in treating patients who are undergoing surgery for stage III or stage IV colorectal adenocarcinoma.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
Radiation: radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Of Radiotherapy And Capecitabine As Pre-Operative Treatment In Patients With Colorectal Cancer|
- Objective tumor response rate [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
- Rate of preservation of functional integrity of the anal sphincter [ Designated as safety issue: No ]
- Comparison of the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation [ Designated as safety issue: No ]
|Study Start Date:||January 2002|
- Determine the objective tumor response rate in patients with stage III or IV colorectal adenocarcinoma treated with neoadjuvant radiotherapy and capecitabine.
- Determine the tolerance profile of this regimen in these patients.
- Determine the rate of preservation of functional integrity of the anal sphincter in patients treated with this regimen.
- Compare the conversion rate from the effects of mutilating surgery vs surgery with sphincter preservation in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral capecitabine twice daily and undergo concurrent radiotherapy 5 days a week on weeks 1-5. Patients undergo surgery on week 6.
Patients are followed every 4 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within 10 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075556
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Dijon, France, 21000|
|Hopital Saint - Louis|
|La Rochelle, France, 17000|
|Centre Jean Bernard|
|Le Mans, France, 72000|
|Clinique Saint Jean|
|Lyon, France, 69008|
|Hopital Notre-Dame de Bon Secours|
|Metz, France, 57038|
|Montfermeil, France, 93370|
|Centre Hospitalier de Mulhouse|
|Mulhouse, France, 68051|
|Paris, France, 75475|
|Paris, France, 75970|
|Senlis, France, 60309|
|Centre Medico-Chirurgical Foch|
|Suresnes, France, 92151|
|OverallOfficial:||Olivier Dupuis, MD||Centre Jean Bernard|