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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00335816 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Fluorouracil may also make tumor cells more sensitive to radiation therapy. Giving radiation therapy together with chemotherapy 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 radiation therapy together with fluorouracil with or without combination therapy works in treating patients who are undergoing surgery for stage II or stage III rectal cancer.
Condition | Intervention | Phase |
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Colorectal Cancer |
Drug: fluorouracil Drug: leucovorin calcium Drug: oxaliplatin Procedure: conventional surgery Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Timing of Rectal Cancer Response to Chemoradiation |
Estimated Enrollment: | 248 |
Study Start Date: | August 2003 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Experimental
Patients undergo chemoradiotherapy comprising radiotherapy once daily 5 days a week for 5 weeks and fluorouracil (5-FU) IV continuously over 24 hours 7 days a week for 5 weeks (weeks 1-5). Patients undergo surgical resection of the rectum in week 12. Patients then receive 9 courses of FOLFOX-6 chemotherapy comprising oxaliplatin, leucovorin calcium, and 5-FU or other chemotherapy off study as directed by the physician.
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Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
Procedure: conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy
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Group 2: Experimental
Patients undergo chemoradiotherapy as in group 1. Beginning in week 10, patients receive FOLFOX-6 chemotherapy comprising oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours followed by bolus 5-FU on day 1 and 5-FU IV continuously over 46 hours on days 1 and 2. Treatment repeats every 14 days for 2 courses. Patients undergo surgical resection of the rectum in week 16. Patients then receive 7 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician. |
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
Procedure: conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy
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Group 3: Experimental
Patients undergo chemoradiotherapy as in group 1. Beginning in week 10, patients receive FOLFOX-6 chemotherapy comprising oxaliplatin, leucovorin calcium, and 5-FU as in group 2. Treatment repeats every 14 days for 4 courses. Patients undergo surgical resection of the rectum in week 20. Patients then receive 5 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician. |
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
Procedure: conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy
|
Group 4: Experimental
Patients undergo chemoradiotherapy as in group 1. Beginning in week 10, patients receive FOLFOX-6 chemotherapy comprising oxaliplatin, leucovorin calcium, and 5-FU as in group 2. Treatment repeats every 14 days for 6 courses. Patients undergo surgical resection of the rectum in week 24. Patients then receive 3 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician. |
Drug: fluorouracil
Given IV
Drug: leucovorin calcium
Given IV
Drug: oxaliplatin
Given IV
Procedure: conventional surgery
Patients undergo surgery
Radiation: radiation therapy
Patients undergo radiotherapy
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OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are assigned to 1 of 4 treatment groups according to time of study enrollment.
Patients then receive 5 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician.
Patients then receive 3 additional courses of FOLFOX-6 chemotherapy or other chemotherapy off study as directed by the physician.
In all groups, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 1 month.
PROJECTED ACCRUAL: A total of 248 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 invasive adenocarcinoma of the rectum
Stage II (T3, N0) or Stage III (any T, N1) disease confirmed by endorectal ultrasound (ERUS) or MRI
PATIENT CHARACTERISTICS:
No history of any of the following significant cardiac diseases:
PRIOR CONCURRENT THERAPY:
United States, California | |
Cancer Care Center at John Muir Health - Concord Campus | Recruiting |
Concord, California, United States, 94524-4110 | |
Contact: Clinical Trials Office - Cancer Care Center at John Muir Healt 925-674-2580 | |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Recruiting |
Orange, California, United States, 92868 | |
Contact: Clinical Trials Office - Chao Family Comprehensive Cancer Cent 877-UC-STUDY ucstudy@uci.edu | |
St. Joseph Hospital Regional Cancer Center - Orange | Recruiting |
Orange, California, United States, 92868-3849 | |
Contact: Theodore Coutsoftides, MD 714-532-2544 | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
United States, District of Columbia | |
Washington Cancer Institute at Washington Hospital Center | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Contact: Clinical Trials Office - Washington Cancer Institute 202-877-8839 | |
United States, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting |
Tampa, Florida, United States, 33612-9497 | |
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org | |
Tampa General Hospital | Recruiting |
Tampa, Florida, United States, 33606 | |
Contact: Jorge E. Marcet, MD 813-844-4545 jmarcet@hsc.usf.edu | |
United States, Illinois | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact: Stephen Hunt, MD 314-454-7204 | |
United States, Nebraska | |
Colon and Rectal Surgery, Incorporated | Recruiting |
Omaha, Nebraska, United States, 68114 | |
Contact: Charles A. Ternent, MD 402-343-1122 | |
United States, Pennsylvania | |
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | Recruiting |
Pittsburgh, Pennsylvania, United States, 15224 | |
Contact: Thomas E. Read, MD, FACS, FASCRS 412-578-6880 tread@wpahs.org | |
Canada, Alberta | |
Tom Baker Cancer Centre - Calgary | Recruiting |
Calgary, Alberta, Canada, T2N 4N2 | |
Contact: William D. Buie, MD 403-944-2020 wdbuie@ucalgary.ca |
Study Chair: | Julio Garcia-Aguilar, MD, PhD | UCSF Helen Diller Family Comprehensive Cancer Center |
Responsible Party: | UCSF Helen Diller Family Comprehensive Cancer Center ( Julio Garcia-Aguilar ) |
Study ID Numbers: | CDR0000458059, UCSF-03451, UCSF-H44287-23127-03, UMN-2003UC036 |
Study First Received: | June 8, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00335816 History of Changes |
Health Authority: | Unspecified |
stage II rectal cancer stage III rectal cancer adenocarcinoma of the rectum |
Antimetabolites Vitamin B Complex Digestive System Neoplasms Immunologic Factors Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Leucovorin Trace Elements Intestinal Diseases Immunosuppressive Agents |
Rectal Diseases Intestinal Neoplasms Calcium, Dietary Oxaliplatin Digestive System Diseases Rectal Cancer Vitamins Fluorouracil Gastrointestinal Neoplasms Micronutrients Adenocarcinoma Colorectal Neoplasms |
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 Digestive System Neoplasms Vitamin B Complex Growth Substances Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms Colorectal Neoplasms |