Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer

Completed · Phase 2

Conditions studied: Gastric Cancer

In brief

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 kill more tumor cells. E7296 was conducted to study neoadjuvant chemotherapy and postoperative chemoradiation therapy in patients diagnosed with high-risk gastric cancer using a new neoadjuvant regimen: paclitaxel plus cisplatin. It was hypothesized that this new neoadjuvant chemotherapy followed by surgery and chemoradiation therapy would be well tolerated and would have a high curative resection rate.

Key facts

Study ID

NCT00003298

Run by

ECOG-ACRIN Cancer Research Group

People needed

39

Starts

1999-06-01

Expected to finish

2011-05-01

Last updated by the study team

2023-07-06

Who can join

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

You may qualify if…

• Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
• Localized cancer that is potentially curable by surgery (T2, N1-2, M0 or T3-4, any N, M0)
• No metastatic cancer to the ovaries
• Age: 18 and over
• Easter Cooperative Oncology Group (ECOG) performance status 0-2
• White blood cell (WBC) count at least 4,000 cells/mm3
• Platelet count at least 150,000/mm3
• Bilirubin less than 2 mg/dL
• Creatinine no greater than 1.5 mg/dL
• Creatinine clearance greater than 50 mL/min
• Caloric intake must be at least 1500 kcal/day
• No prior history of cancer within the past 5 years except for basal cell carcinoma of the skin or in situ carcinoma of the cervix
• No prior radiation therapy, except for skin cancer
• Fertile patients must use adequate contraception
• Met criteria for re-registration after surgery
• T1N1-2M0, T2N1-2M0 or T3-4NanyM0 at time of initial re-registration.
• No evidence of metastatic disease from postoperative pathologic staging.
• ECOG performance status of 0, 1, or 2 at re-registration
• Curative resection performed
• Re-registered 4 - 6 weeks from the date of surgery
• WBC ≥ 4000 cells/mm³, platelets ≥ 150,000/mm³, creatinine ≤ 1.5 mg/dl or creatinine clearance of > 50 ml/min (measured or calculated) and total serum bilirubin < 2 mg/dl, all within four weeks prior to re-registration

You may not qualify if…

• Prior chemotherapy
• Clinically significant auditory impairment
• Significant heart disease
• Pregnant or lactating

Where it is running

• CCOP - Colorado Cancer Research Program, Inc. — Denver, Colorado, United States
• Emory University Hospital - Atlanta — Atlanta, Georgia, United States
• Robert H. Lurie Comprehensive Cancer Center, Northwestern University — Chicago, Illinois, United States
• Veterans Affairs Medical Center - Lakeside Chicago — Chicago, Illinois, United States
• CCOP - Evanston — Evanston, Illinois, United States
• CCOP - Carle Cancer Center — Urbana, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• Veterans Affairs Medical Center - Indianapolis (Roudebush) — Indianapolis, Indiana, 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
• CCOP - Ann Arbor Regional — Ann Arbor, Michigan, United States
• CCOP - Kalamazoo — Kalamazoo, Michigan, United States
• CCOP - Metro-Minnesota — Saint Louis Park, Minnesota, United States
• CCOP - Missouri Valley Cancer Consortium — Omaha, Nebraska, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Raritan Bay Medical Center — Perth Amboy, New Jersey, United States
• Somerset Medical Center — Somerville, New Jersey, United States
• University of Rochester Cancer Center — Rochester, New York, United States
• Albert Einstein Comprehensive Cancer Center — The Bronx, New York, United States
• Ireland Cancer Center — Cleveland, Ohio, United States
• CCOP - Toledo Community Hospital Oncology Program — Toledo, Ohio, United States
• University of Pennsylvania Cancer Center — Philadelphia, Pennsylvania, United States
• CCOP - MainLine Health — Wynnewood, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.