Combination Chemotherapy Plus Radiation Therapy With or Without Fluorouracil in Treating Patients With Cancer of the Esophagus or Stomach
NCT ID: NCT00009880
Last Updated: 2013-07-19
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
2001-04-30
Brief Summary
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PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus radiation therapy with and without fluorouracil in treating patients who have cancer of the esophagus or stomach.
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Detailed Description
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* Compare the survival and failure patterns in patients with previously untreated carcinoma of the esophagus or gastroesophageal junction treated with cisplatin, paclitaxel, and concurrent radiotherapy with or without fluorouracil.
* Compare the tolerance of these regimens by these patients.
* Compare the overall quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to percentage of weight loss (less than 10% vs 10% or more), disease histology (adenocarcinoma vs squamous cell carcinoma), and lesion size (no more than 5 cm vs more than 5 cm). Patients are randomized to one of two treatment arms.
* Arm I: Patients receive induction chemotherapy comprising fluorouracil IV continuously over 24 hours and cisplatin IV over 1 hour on days 1-5, paclitaxel IV continuously over 24 hours on day 1, and filgrastim (G-CSF) subcutaneously daily on days 6-15. Treatment repeats every 4 weeks for up to 2 courses. Patients with stable or responsive disease after the first course of induction therapy receive a second course of therapy. Patients with local disease progression after the first course proceed to chemoradiotherapy.
Beginning on day 29 of the last course of induction chemotherapy, patients undergo radiotherapy 5 days a week for 5.5 weeks. Patients also receive fluorouracil IV continuously over 24 hours on days 1-5, 8-12, 15-19, 22-26, and 29-33, and paclitaxel IV over 3 hours on days 1, 8, 15, 22, and 29.
* Arm II: Patients receive induction chemotherapy comprising cisplatin IV and paclitaxel IV over 3 hours on day 1. Treatment continues every 3 weeks for 2 courses as in arm I.
Beginning on day 29 of the last course of induction chemotherapy, patients undergo radiotherapy as in arm I. Patients also receive cisplatin IV on days 1, 8, 15, 22, 29, and 36, and paclitaxel IV continuously over 96 hours on days 1-4, 8-11, 15-18, 22-25, 29-32, and 36-39.
Quality of life is assessed at baseline, within 1 week after radiotherapy, at 6 weeks after study completion, every 4 months for 1 year, every 6 months for 2 years, and then annually for 5 years.
Patients are followed within 8 weeks, every 4 months for 1 year, every 6 months for two years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 84 patients (42 per treatment arm) will be accrued for this study within 21 months.
Conditions
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Study Design
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TREATMENT
Interventions
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filgrastim
cisplatin
fluorouracil
paclitaxel
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed primary squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction
* Stage I-III (T1, N1, M0; T2-4, N any, M0)
* Supraclavicular or celiac lymph node involvement allowed
* Disease entirely confined to the esophagus or gastroesophageal junction and peri-esophageal soft tissue
* Cervical esophageal carcinoma allowed
* No tumor extension beyond 2 cm into stomach
* No multiple primary carcinomas of the esophagus
* No evidence of disseminated cancer
* No tracheoesophageal fistula or direct invasion into the mucosa of the trachea or major bronchi
* Bronchoscopy with biopsy and cytology required if the primary carcinoma is less than 26 cm from the incisors or is at or above the carina by imaging study
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 150,000/mm\^3
* Hemoglobin at least 10 g/dL
Hepatic:
* Not specified
Renal:
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 65 mL/min
Cardiovascular:
* No uncontrolled heart disease
* No uncontrolled hypertension
Other:
* Total oral/enteral intake must be at least 1,700 kCal/day
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No uncontrolled diabetes
* No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior systemic chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior chest radiotherapy
Surgery:
* No prior major esophageal surgery
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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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Foundation for Cancer Research and Education
Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Leavey Cancer Center at Northridge Hospital Medical Center
Northridge, California, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Baptist-South Miami Regional Cancer Program
Miami, Florida, United States
CCOP - Mount Sinai Medical Center
Miami Beach, Florida, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Union Hospital
Terre Haute, Indiana, United States
Wendt Regional Cancer Center at Finley Hospital
Dubuque, Iowa, United States
Esther Marie Hatton Cancer Care Center at St. Elizabeth Medical Center
Edgewood, Kentucky, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States
CCOP - Kansas City
Kansas City, Missouri, United States
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States
Monmouth Medical Center
Long Branch, New Jersey, United States
Atlantic City Medical Center - Mainland Division
Pomona, New Jersey, United States
Community Medical Center
Toms River, New Jersey, United States
SUNY Downstate Medical Center
Brooklyn, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States
Akron General's McDowell Cancer Center
Akron, Ohio, United States
Akron City Hospital at Summa Health System
Akron, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Mount Carmel West Hospital
Columbus, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States
Delaware County Regional Cancer Center at Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
East Stroudsburg, Pennsylvania, United States
Cancer Center at Paoli Memorial Hospital
Paoli, Pennsylvania, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital and Medical Center
Reading, Pennsylvania, United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States
Cottonwood Hospital Medical Center
Murray, Utah, United States
McKay-Dee Hospital Center
Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Dixie Regional Medical Center
St. George, Utah, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States
Countries
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References
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Ajani JA, Winter K, Komaki R, Kelsen DP, Minsky BD, Liao Z, Bradley J, Fromm M, Hornback D, Willett CG. Phase II randomized trial of two nonoperative regimens of induction chemotherapy followed by chemoradiation in patients with localized carcinoma of the esophagus: RTOG 0113. J Clin Oncol. 2008 Oct 1;26(28):4551-6. doi: 10.1200/JCO.2008.16.6918. Epub 2008 Jun 23.
Komaki R, Winter K, Ajani J: Non-operative therapy of local-regional carcinoma of the esophagus: a randomized phase II study of two paclitaxel-based chemoradiotherapy regimens (RTOG 0113). [Abstract] The American Radium Society 89th Annual Meeting, May 5-29, 2007, Amsterdam, Netherlands. A-SS-2, 1, 2007.
Komaki R, Winter K, Ajani A, et al.: A randomized phase II study of two paclitaxel-based chemoradiotherapy regimens for patients with the non-operative esophageal carcinoma (RTOG 0113). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-142, S79-80, 2006.
Other Identifiers
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CDR0000068420
Identifier Type: -
Identifier Source: secondary_id
RTOG-0113
Identifier Type: -
Identifier Source: org_study_id
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