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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00711412 |
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy and 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 capecitabine and oxaliplatin together with radiation therapy works in treating patients with esophageal or gastroesophageal junction cancer.
Condition | Intervention | Phase |
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Esophageal Cancer |
Drug: capecitabine Drug: oxaliplatin Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Capecitabine and Oxaliplatin With Radiation for Esophageal and Gastroesophageal Junction Adenocarcinoma |
Estimated Enrollment: | 43 |
Study Start Date: | October 2005 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study treatment, patients are followed every 3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
No evidence of CNS metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu |
Principal Investigator: | Mary Mulcahy, MD | Robert H. Lurie Cancer Center |
Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Mary Mulcahy ) |
Study ID Numbers: | CDR0000599730, NU-0512, NU-IRB-0948-009 |
Study First Received: | July 5, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00711412 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the esophagus stage I esophageal cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Oxaliplatin |
Digestive System Diseases Esophageal Disorder Head and Neck Neoplasms Gastrointestinal Neoplasms Esophageal Diseases Adenocarcinoma |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Esophageal Neoplasms Pharmacologic Actions |
Neoplasms Oxaliplatin Digestive System Diseases Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Gastrointestinal Neoplasms Esophageal Diseases |