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

Clinical trial: Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus

Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with surgery is more effective than surgery alone.
  PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients with cancer of the esophagus.

Detailed description: OBJECTIVES:
  -  Compare survival in patients with operable adenocarcinoma of the lower third of the esophagus or the cardia treated with fluorouracil/cisplatin vs. no chemotherapy prior to surgical resection.
  -  Assess whether neoadjuvant fluorouracil/cisplatin increases tumor resectability.
  OUTLINE: This study is randomized for neoadjuvant chemotherapy. Patients are stratified by performance status, tumor location, and randomizing center.
  Patients randomized to no neoadjuvant chemotherapy undergo resection of the tumor with adequate margins and resection of regional lymph nodes (R2 with at least 8 nodal groups recommended).
  Patients randomized to neoadjuvant chemotherapy receive fluorouracil and cisplatin at 3-4 week intervals; fluorouracil is given by continuous intravenous infusion for 5 days and cisplatin is given on the first 2 days of fluorouracil administration. Tumor response is assessed after 2 courses; responding patients with no serious toxicity receive a third course. Surgery, as above, is initiated 4-6 weeks after the second or third course of chemotherapy. Upon recovery (within 3-6 weeks), patients who responded to neoadjuvant chemotherapy receive 3-4 additional courses of postoperative chemotherapy (maximum total of 6 courses). Patients whose best response was stable disease are assessed for postoperative radiotherapy.
  Patients on either arm with positive resection margins, positive lymph nodes, or equivocal complete resection are referred for postoperative radiotherapy. Further therapy for patients with incomplete resection is at the discretion of the physician.
  Patients are followed every 3-4 months for at least 5 years.
  PROJECTED ACCRUAL: A total of 250 patients will be entered.

Eligibility: DISEASE CHARACTERISTICS:
  -  Adenocarcinoma of the lower third of the esophagus or the cardia for which complete resection is feasible
  -  Extension to the cardia allowed
  -  Cancer of the cardia with extension to the esophagus or stomach allowed
  -  No in situ cancer of the cardia
  -  No distant metastases
  PATIENT CHARACTERISTICS:
  Age:
  -  Not over 75
  Performance status:
  -  WHO 0 or 1
  Hematopoietic:
  -  WBC at least 4,000
  -  Polymorphonuclear lymphocytes greater than 2,000
  -  Platelets at least 100,000
  Hepatic:
  -  Not specified
  Renal:
  -  Creatinine less than 1.3 mg/dL (120 micromoles/L)
  Cardiovascular:
  -  No prior myocardial infarction
  -  No other cardiac contraindication to surgery
  Pulmonary:
  -  No respiratory contraindication to surgery
  Other:
  -  No second malignancy except:
  -  Basal cell carcinoma of the skin
  -  Adequately treated in situ carcinoma of the uterine cervix
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  No prior chemotherapy for tumors of the cardia
  Endocrine therapy
  -  No prior radiotherapy for tumors of the cardia
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified

Relevance to patient case: not relevant