Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer

Completed · Phase 2

Conditions studied: Esophageal Cancer, Gastric Cancer

In brief

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy before and after surgery may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer.

Key facts

Study ID

NCT00033657

Run by

Eastern Cooperative Oncology Group

People needed

97

Starts

2002-08-15

Expected to finish

2009-10-01

Last updated by the study team

2023-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction
• Stage T2-3, N0, M0 OR
• Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis)
• Tumor must be considered surgically resectable (T1-3, but not T4)
• Age>=18 years
• ECOG Performance status 0-1
• Adequate hematopoietic, hepatic, renal functions defined by the following within 4 weeks prior to randomization:
• Granulocyte count at least 1,000/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin no greater than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years
• Fertile patients must use effective contraception
• Endoscopy with biopsy and dilation allowed

You may not qualify if…

• Tumor extends more than 2 cm into the cardia
• Pregnant or nursing
• Other concurrent illness that would preclude study therapy or surgical resection
• Concurrent filgrastim (G-CSF) during study radiotherapy
• Prior chemotherapy
• Prior radiotherapy
• Prior surgery

Where it is running

• CCOP - Colorado Cancer Research Program, Incorporated — Denver, Colorado, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Shands Cancer Center at the University of Florida Health Science Center — Gainesville, Florida, United States
• Veterans Affairs Medical Center - Lakeside Chicago — Chicago, Illinois, United States
• Robert H. Lurie Comprehensive Cancer Center at Northwestern University — Chicago, Illinois, United States
• CCOP - Carle Cancer Center — Urbana, Illinois, United States
• CCOP - Iowa Oncology Research Association — Des Moines, Iowa, United States
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• CCOP - Michigan Cancer Research Consortium — Ann Arbor, Michigan, United States
• Mayo Clinic Cancer Center — Rochester, Minnesota, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• St. Joseph's Hospital — Saint Paul, Minnesota, United States
• Cancer Institute of New Jersey at Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States
• Ireland Cancer Center — Cleveland, Ohio, United States
• MetroHealth's Cancer Care Center at MetroHealth Medical Center — Cleveland, Ohio, United States
• CCOP - Toledo Community Hospital — Toledo, Ohio, United States
• CCOP - MainLine Health — Wynnewood, Pennsylvania, United States
• Lankenau Cancer Center at Lankenau Hospital — Wynnewood, Pennsylvania, United States
• CCOP - Sioux Community Cancer Consortium — Sioux Falls, South Dakota, United States
• CCOP - Scott and White Hospital — Temple, Texas, United States
• CCOP - St. Vincent Hospital Cancer Center, Green Bay — Green Bay, Wisconsin, United States
• University of Wisconsin Comprehensive Cancer Center — Madison, Wisconsin, United States
• CCOP - Marshfield Clinic Research Foundation — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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