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Sponsors and Collaborators: |
Fox Chase Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00084591 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may cause less damage to normal tissue. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving radiation therapy together with chemotherapy before surgery may shrink the tumor so it can be removed.
PURPOSE: This phase I trial is studying the side effects and best dose of neoadjuvant intensity-modulated radiation therapy with incorporated boost when given together with capecitabine in treating patients with locally advanced rectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: capecitabine Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study of Preoperative Intensity Modulated Radiation Therapy (IMRT) With Incorporated Boost and Oral Capecitabine in Locally Advanced Rectal Cancer |
Study Start Date: | December 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of boost intensity-modulated radiotherapy (IMRT).
Patients undergo neoadjuvant IMRT with incorporated boost once daily 5 days a week for 5 weeks. Beginning on the first day of radiotherapy, patients receive oral capecitabine twice daily 7 days a week for 5 weeks. Patients undergo surgical resection 4-8 weeks after completion of chemoradiotherapy.
Cohorts of 3-6 patients undergo escalating doses of boost IMRT until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity.
Quality of life is assessed at baseline, at week 5 of chemoradiotherapy, before surgery, and then at 1, 3, and 12 months after surgery.
Patients are followed at 1, 3, and 12 months after surgery.
PROJECTED ACCRUAL: Approximately 3-15 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 rectum
Clinical stage T3-4, N1-2 (stage II or III) disease by 2 of the following tests:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111-2497 |
Principal Investigator: | Gary Freedman, MD | Fox Chase Cancer Center |
Study ID Numbers: | CDR0000365462, FCCC-03606 |
Study First Received: | June 10, 2004 |
Last Updated: | October 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00084591 |
Health Authority: | United States: Federal Government |
stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum |
Capecitabine Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Rectal neoplasm Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Rectal cancer Colorectal Neoplasms |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |