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Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum Clinical research trials and Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum. Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum  Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
For Condition: stage 2 rectal cancer,stage 3 rectal cancer,adenocarcinoma of the rectum
Status: No longer recruiting
Sponsor(s): Cancer and Leukemia Group B , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy, radiation therapy, and surgery may be a more effective treatment for cancer of the rectum. PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin, fluorouracil, and external-beam radiation therapy followed by surgery in treating patients who have locally advanced cancer of the rectum.
Details: OBJECTIVES: - Determine the maximum tolerated dose of oxaliplatin when combined with fluorouracil and external beam radiotherapy in patients with locally advanced adenocarcinoma of the rectum. (Phase I closed to accrual effective 03/27/2003). - Determine the pathological response rate in patients treated with this preoperative regimen and surgical resection. - Determine the late toxicity of this preoperative regimen in these patients. - Determine, in a preliminary manner, the progression-free survival, local control, and overall survival in patients treated with this regimen. OUTLINE: This is a dose-escalation, multicenter study of oxaliplatin. Patients receive oxaliplatin IV over 1 hour on day 1, fluorouracil IV continuously on days 1-7, and radiotherapy on days 1-5. Treatment repeats weekly for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level in the phase II portion of the study. (Phase I closed to accrual effective 03/27/2003). Patients may undergo radical resection of rectal tumor within 4-6 weeks after completion of chemoradiotherapy. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for phase I of the study (phase I closed to accrual effective 03/27/2003) and a total of 19 patients will be accrued for phase II of the study within 12-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven previously untreated adenocarcinoma of the rectum that begins within 12 cm of the anal verge by sigmoidoscopy and/or colonoscopy - Locally advanced disease defined as any of the following: - Fixed or immovable tumor on physical exam - T4 disease with invasion of adjacent structures (e.g., pelvic sidewall, sacral pelvis, bladder, or prostate) by CT scan, rectal ultrasound, or MRI - T3 disease with invasion through the wall of the muscularis propria by transrectal ultrasound, CT scan, or MRI - No distant metastatic disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGOT/SGPT no greater than 2.5 times ULN Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other: - No active second malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix - Patients are not considered to have an active second malignancy if they have completed therapy and are at less than 30% risk of relapse - No prior or concurrent evidence of neuropathy - No history of allergy to platinum compounds or antiemetics - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior fluorouracil or platinum-based therapy for any malignancy - No other concurrent chemotherapy Endocrine therapy: - Hormonal therapy allowed only for non-disease related conditions (e.g., insulin for diabetes) OR intermittently as an antiemetic (e.g., dexamethasone) Radiotherapy: - No prior pelvic irradiation Surgery: - Not specified Other: - No concurrent antiretroviral therapy (HAART) for HIV positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidRyan, Study Chair, Massachusetts General Hospital
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 24014
United States
Veterans Affairs Medical Center - Fargo
Fargo, North Dakota, 58102
United States
Saint Anthony Medical Center
Rockford, Illinois, 61108
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
NorthEast Oncology Associates
Concord, North Carolina, 28025
United States
Cooper University Hospital
Camden, New Jersey, 08103
United States
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, 05401-3498
United States
Veterans Affairs Medical Center - Baltimore
Baltimore, Maryland, 21201
United States
Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Veterans Affairs Medical Center - Washington, DC
Washington D.C., District of Columbia, 20422
United States
Ministry Medical Group - Northern Region
Rhinelander, Wisconsin, 54501
United States
Lakeland Medical Center - St. Joseph
Saint Joseph, Michigan, 49085
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
Fort Wayne Medical Oncology and Hematology, Incorporated
Ft. Wayne, Indiana, 46885-5099
United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
Veterans Affairs Medical Center - Las Vegas
Las Vegas, Nevada, 89106
United States
Elmhurst Hospital Center
Elmhurst, New York, 11373
United States
St. Mary's Medical Center
Huntington, West Virginia, 25701
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
UCSF Comprehensive Cancer Center
San Francisco, California, 94115
United States
Helen and Harry Gray Cancer Institute at Good Samaritan Medical Center
West Palm Beach, Florida, 33401
United States
Lenoir Memorial Hospital Cancer Center
Kinston, North Carolina, 28503-1678
United States
Veterans Affairs Medical Center - Dallas
Dallas, Texas, 75216
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Veterans Affairs Medical Center - San Diego
San Diego, California, 92161
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Baptist Hospital East - Louisville
Louisville, Kentucky, 40207
United States
Martha Jefferson Hospital
Charlottesville, Virginia, 22902
United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28302-2000
United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , 00936-5067
Puerto Rico
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640
United States
Virginia Oncology Associates - Norfolk
Norfolk, Virginia, 23502
United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305
United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, 65203
United States
New Hanover Regional Medical Center
Wilmington, North Carolina, 28402-9025
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Veterans Affairs Medical Center - Asheville
Asheville, North Carolina, 28805
United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432
United States
Memorial Regional Hospital Comprehensive Cancer Center
Hollywood, Florida, 33021
United States
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36207
United States
Additional Information:
Study ID Numbers: CDR0000068099; CLB-89901
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006094
Other Adenocarcinoma Of The Rectum Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
2. SU5416 in Treating Patients With Metastatic or Locally Recurrent Colorectal Cancer
3. Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Rectal Cancer
4. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
5. J-Pouch Coloanal Anastomosis Compared With Side-to-End Coloanal Anastomosis After Radiation Therapy and Surgery to Remove the Rectum in Treating Patients With Rectal Adenocarcinoma
Related Studies:
Other adenocarcinoma of the rectum Clinical Trials
Other North Carolina Clinical Trials
Other Winston Salem Clinical Trials
Oxaliplatin, Fluorouracil, and External-Beam Radiation Therapy Followed by Surgery in Treating Patients With Locally Advanced Cancer of the Rectum
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