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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00335959 |
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving oxaliplatin and capecitabine together with radiation therapy works in treating patients with stomach cancer that can be removed by surgery.
Condition | Intervention | Phase |
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Gastric Cancer |
Drug: capecitabine Drug: oxaliplatin Genetic: comparative genomic hybridization Genetic: microarray analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Neoadjuvant Chemoradiation Therapy With Oxaliplatin and Capecitabine for Patients With Surgically Resectable Gastric Cancer: A Pilot Phase II Trial With Molecular Correlates |
Estimated Enrollment: | 75 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, pilot study.
Tumor tissue is obtained at surgery or endoscopic biopsy. Gene expression analysis and comparative genomic hybridization testing are conducted on the tissue. Blood is drawn prior to beginning study treatment and is analyzed for germline polymorphisms.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary adenocarcinoma of the stomach, meeting the following criteria:
Enlarged lymph nodes outside of radiation fields must have preoperative biopsies
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Investigator: | Lawrence P. Leichman, MD | Desert Regional Medical Center Comprehensive Cancer Center |
Study Chair: | Syed A. Ahmad, MD | Barrett Cancer Center |
Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
Study ID Numbers: | CDR0000476577, SWOG-S0425 |
Study First Received: | June 8, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00335959 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the stomach stage I gastric cancer stage II gastric cancer stage III gastric cancer |
Antimetabolites Oxaliplatin Capecitabine Stomach Diseases Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms Stomach Cancer Adenocarcinoma |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Pharmacologic Actions |
Neoplasms Oxaliplatin Neoplasms by Site Digestive System Diseases Stomach Diseases Stomach Neoplasms Therapeutic Uses Gastrointestinal Neoplasms |