Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Chemotherapy and Radiation Therapy in Treating Patients With Stomach Cancer

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 with radiation therapy may kill more tumor cells.
  PURPOSE: Phase II trial to study the effectiveness of chemotherapy and radiation therapy in treating patients who have stomach cancer.

Detailed description: OBJECTIVES:
  -  Determine the feasibility of preoperative chemoradiotherapy in patients with potentially resectable adenocarcinoma of the stomach.
  -  Determine the pathologic response rate, curative resection rate, and survival in patients treated with this regimen.
  -  Determine the tolerability of this regimen in these patients.
  OUTLINE: Patients receive fluorouracil IV over 24 hours on days 1-21, cisplatin IV over 1 hour on days 1-5, and leucovorin calcium IV over 15 minutes on days 1, 8, 15, and 22. A second course is administered beginning on day 29.
  Chemoradiotherapy begins at the end of the second course of chemotherapy and 1 week of rest (day 57). Patients receive fluorouracil IV over 24 hours 5 days a week concurrently with radiotherapy for 5 weeks and paclitaxel IV over 3 hours once weekly during these 5 weeks on days 1, 8, 15, 22, and 29.
  Approximately 4-5 weeks after chemoradiotherapy, patients with no evidence of metastatic disease undergo surgical resection.
  Patients are followed every 3 months for 1 year, every 6 months for 5 years, then annually thereafter.
  PROJECTED ACCRUAL: A total of 21-49 patients will be accrued for this study within 2.5 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven adenocarcinoma of the stomach
  -  Stage IB, II, IIIA, IIIB, and IV (T2-3, any N, M0)
  -  No lymph node metastases outside the field of resection (e.g., supraclavicular, mediastinal, or paraaortic nodes)
  -  Potentially resectable
  -  May involve the gastroesophageal junction, but bulk of tumor must be in the stomach
  -  No distant metastases
  -  No pleural or pericardial effusion
  -  No peritoneal disease diagnosed by laparoscopy
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  Zubrod 0-2
  Life expectancy:
  -  At least 16 weeks
  Hematopoietic:
  -  Absolute granulocyte count greater than 2,000/mm^3
  -  Platelet count greater than 100,000/mm^3
  Hepatic:
  -  Bilirubin no greater than 1.5 mg/dL
  Renal:
  -  Creatinine less than 1.5 mg/dL
  Cardiovascular:
  -  No New York Heart Association class III or IV heart disease
  -  No hypertension
  Neurologic:
  -  No cerebrovascular disease
  -  No diabetic neuropathy
  -  No mental status abnormalities
  Other:
  -  No uncontrolled diabetes
  -  No infection
  -  No other malignancies within past 5 years except resected squamous cell or basal cell skin cancer
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  No prior immunotherapy
  Chemotherapy:
  -  No prior chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  No prior radiotherapy to stomach
  Surgery:
  -  No prior surgery to stomach

Relevance to patient case: not relevant