Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
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|ClinicalTrials.gov Identifier: NCT00003862|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 19, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: cisplatin Drug: fluorouracil Drug: leucovorin calcium Drug: paclitaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 2|
- Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach.
- Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29.
Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29.
Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Preoperative Chemotherapy and Chemoradiotherapy for Potentially Resectable Adenocarcinoma of the Stomach|
|Study Start Date :||November 1999|
|Actual Primary Completion Date :||November 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003862
Show 55 Study Locations
|Study Chair:||Jaffer A. Ajani, MD||M.D. Anderson Cancer Center|