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| Sponsor: | Radiation Therapy Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00613080 |
Purpose
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with intensity-modulated radiation therapy works in treating patients undergoing surgery for locally advanced rectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: capecitabine Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: adjuvant therapy Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Radiation: 3-dimensional conformal radiation therapy Radiation: intensity-modulated radiation therapy |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) in Combination With Capecitabine and Oxaliplatin for Patients With Locally Advanced Rectal Cancer |
| Estimated Enrollment: | 75 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are followed every 3 months after the start of treatment for 2 years, every 6 months for years 3-5, and then annually thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Pathologically confirmed diagnosis of adenocarcinoma of the rectum by biopsy technique that does not completely excise the lesion (e.g., fine needle aspiration, core needle biopsy)
Stage IIIB-IIIC disease (T3-T4, N0-2, M0)(i.e., without evidence of distant metastases) tumor as determined by the following assessments:
Transrectal ultrasound (TRUS) within the past 8 weeks required to establish tumor stage
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Severe, active comorbidity, defined as follows:
PRIOR CONCURRENT THERAPY:
Contacts and Locations
Show 120 Study Locations| Study Chair: | Michael C. Garofalo, MD | University of Maryland Greenebaum Cancer Center |
| Investigator: | Adam C. Berger, MD | Kimmel Cancer Center (KCC) |
| Investigator: | Johanna Bendell, MD | Duke University |
More Information
| Responsible Party: | Radiation Therapy Oncology Group ( Walter John Curran, Jr ) |
| Study ID Numbers: | CDR0000586277, RTOG-0822 |
| Study First Received: | February 9, 2008 |
| Last Updated: | November 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00613080 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage III rectal cancer adenocarcinoma of the rectum |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Rectal Neoplasms Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Capecitabine Vitamin B Complex Digestive System Neoplasms Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |