Spots Global Cancer Trial Database for Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach
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Trial Identification
Brief Title: Combination Chemotherapy After Surgery in Treating Patients With Cancer of the Esophagus or Stomach
Official Title: Phase II Trial of Post-Operative Adjuvant Paclitaxel + Cisplatin in Patients With Adenocarcinoma of the Esophagus, Gastro-Esophageal Junction or Cardia
Study ID: NCT00003237
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug, and giving them after surgery, may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, consisting of paclitaxel and cisplatin, given after surgery in treating patients with cancer of the esophagus or stomach.
Detailed Description: OBJECTIVES: I. Evaluate the disease free survival and overall survival of patients with adenocarcinoma of the esophagus, gastroesophageal junction, or cardia receiving post-operative adjuvant paclitaxel plus cisplatin. OUTLINE: Patients undergo esophagogastrectomies within 4-12 weeks prior to the study. Patients receive intravenous paclitaxel over 3 hours on day 1, followed by intravenous cisplatin. Treatment is repeated every 21 days for 4 courses. Patients exhibiting disease recurrence or unacceptable toxic effects are removed from the study. Patients are followed every 3 months for 2 years, every 6 months for the next 3 years, and then every 12 months thereafter. PROJECTED ACCRUAL: A total of 55 patients will be accrued within 16 months.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Lakeside), Chicago, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois, United States
CCOP - Central Illinois, Springfield, Illinois, United States
CCOP - Carle Cancer Center, Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa, United States
CCOP - Ochsner, New Orleans, Louisiana, United States
New England Medical Center Hospital, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
CCOP - Ann Arbor Regional, Ann Arbor, Michigan, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
CCOP - Northern New Jersey, Hackensack, New Jersey, United States
Albert Einstein Comprehensive Cancer Center, Bronx, New York, United States
Veterans Affairs Medical Center - New York, New York, New York, United States
Kaplan Cancer Center, New York, New York, United States
CCOP - Merit Care Hospital, Fargo, North Dakota, United States
Ireland Cancer Center, Cleveland, Ohio, United States
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center, Tulsa, Oklahoma, United States
Allegheny University Hospitals- Hahnemann, Philadelphia, Pennsylvania, United States
University of Pennsylvania Cancer Center, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
CCOP - MainLine Health, Wynnewood, Pennsylvania, United States
Veterans Affairs Medical Center - Madison, Madison, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - San Juan, San Juan, , Puerto Rico
Pretoria Academic Hospital, Pretoria, , South Africa
Contact Details
Name: Arlene A. Forastiere, MD
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Role: STUDY_CHAIR
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