Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
Condition: Esophageal Cancer; Gastric Cancer
MeSH terms: Stomach Neoplasms; Esophageal Neoplasms
Intervention: cisplatin; irinotecan hydrochloride; paclitaxel; conventional surgery; radiation therapy
Intervention description: Days 1 - 35 : Cisplatin 30 mg/m² days 1, 8, 15, 22, 29
Days 63 - 77 : cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles; Days 1 - 35 : Irinotecan 65 mg/m² days 1, 8, 22, 29
Days 63 - 77 : irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles; Days 1 - 35 : Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29
Days 63 - 77 : paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles; The type of resection (lvor-Lewis, Transhiatal, etc.) was left to the discretion of the operating surgeon. One lymph node dissection was required.; The total dose to the prescription point was 4500 cGy given in 25 fractions. The patient was treated with one fraction per day with all fields treated per day. 180 cGy was delivered to the isocenter. If the dose to the supraclavicular fossa (SCF) was less than 4500 cGy, a localized photon or electron boost was allowed in order to increase the SCF dose to 4500 cGy, specified at 3 cm depth from the anterior skin surface.
Intervention MeSH terms: Paclitaxel; Camptothecin; Cisplatin; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage I gastric cancer; stage II gastric cancer; stage III gastric cancer; stage IV gastric cancer; stage I esophageal cancer; stage II esophageal cancer; stage III esophageal cancer; stage IV esophageal cancer; adenocarcinoma of the stomach; adenocarcinoma of the esophagus

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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