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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ECOG-ACRIN Cancer Research Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Calcium; Cisplatin; Fluorouracil; Formyltetrahydrofolates; Leucovorin; Levoleucovorin; Paclitaxel; Tetrahydrofolates

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Prior chemotherapy

• Clinically significant auditory impairment

• Significant heart disease

• Pregnant or lactating