Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: cisplatin; fluorouracil; leucovorin calcium; paclitaxel; surgery; radiation therapy
Intervention description: Cisplatin was administered as part of the neoadjuvant regimen. It was given at a dose of 75 mg/m² via IV over approximately one hour, on day 1 of each cycle. Three cycles were given.; Postoperative regimen 5-FU, along with Leucovorin, was given by IV bolus, with 5-FU given immediately after the Leucovorin; Both 5-FU and Leucovorin will be given via IV bolus, with Leucovorin given immediately before 5-FU.; Paclitaxel was administered as part of the neoadjuvant regimen. It was given at a dose of 175 mg/m² as a 3 hour continuous intravenous infusion on day 1. Three cycles were given.; The surgical procedure performed involved a radical subtotal or total gastrectomy.
A complete surgical resection was required; Concomitant chemotherapy and radiation therapy course: 5-FU 400 mg/m²/day + Leucovorin 20 mg/m²/day on days 1-4 of week one and days 1-3 of week 5 of XRT. Combined chemotherapy and radiation therapy were to begin 4 weeks after day 1 of the initial course of chemotherapy
Intervention MeSH terms: Leucovorin; Tetrahydrofolates; Formyltetrahydrofolates; Paclitaxel; Cisplatin; Fluorouracil; Calcium; Levoleucovorin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; adenocarcinoma of the stomach

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.
    

Eligibility 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