Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer
NCT ID: NCT00003862
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-11-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.
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Detailed Description
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* Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach.
* Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen.
* Determine the tolerability of this regimen in these patients.
OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29.
Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29.
Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter.
PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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cisplatin
fluorouracil
leucovorin calcium
paclitaxel
conventional surgery
neoadjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically proven adenocarcinoma of the stomach
* Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)
* No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes)
* Potentially resectable
* May involve the gastroesophageal junction, but bulk of tumor must be in the stomach
* No distant metastases
* No pleural or pericardial effusion
* No peritoneal disease diagnosed by laparoscopy
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Zubrod 0-2
Life expectancy:
* At least 16 weeks
Hematopoietic:
* Absolute granulocyte count greater than 2,000/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
Renal:
* Creatinine less than 1.5 mg/dL
Cardiovascular:
* No New York Heart Association class III or IV heart disease
* No hypertension
Neurologic:
* No cerebrovascular disease
* No diabetic neuropathy
* No mental status abnormalities
Other:
* No uncontrolled diabetes
* No infection
* No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior immunotherapy
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to stomach
Surgery:
* No prior surgery to stomach
0 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Jaffer A. Ajani, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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Providence Alaska Medical Center
Anchorage, Alaska, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, United States
Mount Diablo Medical Center
Concord, California, United States
Northridge Hospital Medical Center
Northridge, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Penrose - St. Francis Health Services
Colorado Springs, Colorado, United States
St. Joseph Hospital
Denver, Colorado, United States
Presbyterian-St Luke's Medical Center
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
Lutheran General Hospital Cancer Care Center
Park Ridge, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
Ball Memorial Hospital Cancer Center
Muncie, Indiana, United States
Porter Memorial Hospital
Valparaiso, Indiana, United States
Wendt Regional Cancer Center of Finley Hospital
Dubuque, Iowa, United States
McLaren Regional Cancer Center
Flint, Michigan, United States
Ellis Fischel Cancer Center at University of Missouri - Columbia
Columbia, Missouri, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States
Norris Cotton Cancer Center at Dartmouth Medical School
Lebanon, New Hampshire, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital
Mount Holly, New Jersey, United States
Fox Chase Cancer Center at St. Francis Medical Center
Trenton, New Jersey, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States
Presbyterian Hospital
Charlotte, North Carolina, United States
Wayne Memorial Hospital, Inc.
Goldsboro, North Carolina, United States
Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina
Greenville, North Carolina, United States
Ireland Cancer Center
Cleveland, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Mercy Fitzgerald Hospital
Darby, Pennsylvania, United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
Harrington Cancer Center
Amarillo, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
University of Washington Medical Center
Seattle, Washington, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Columbia Hospital
Milwaukee, Wisconsin, United States
Countries
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References
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Ajani JA, Winter K, Okawara GS, Donohue JH, Pisters PW, Crane CH, Greskovich JF, Anne PR, Bradley JD, Willett C, Rich TA. Phase II trial of preoperative chemoradiation in patients with localized gastric adenocarcinoma (RTOG 9904): quality of combined modality therapy and pathologic response. J Clin Oncol. 2006 Aug 20;24(24):3953-8. doi: 10.1200/JCO.2006.06.4840.
Okawara GS, Winter K, Donohue JH, et al.: A phase II trial of preoperative chemotherapy and chemoradiotherapy for potentially resectable adenocarcinoma of the stomach (RTOG 99-04). [Abstract] J Clin Oncol 23 (Suppl 16): A-4019, 312s, 2005.
Other Identifiers
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CDR0000067026
Identifier Type: -
Identifier Source: secondary_id
RTOG-9904
Identifier Type: -
Identifier Source: org_study_id
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