Patient case: 60-year-old female with gastric cancer; genetic feature: EGFR

Clinical trial: Assessing Quality of Life of Patients With Stomach Cancer

Summary: RATIONALE: Assessing quality of life in patients who are undergoing cancer treatment may help determine the effect of treatment on these patients.
  PURPOSE: Clinical trial to study the effectiveness of a quality of life assessment in patients who are receiving treatment for stomach cancer.

Detailed description: OBJECTIVES:
  -  Determine the scale structure, reliability, and validity of the tumor-specific questionnaire, QLQ-STO22, in assessing the quality of life of patients with gastric cancer.
  -  Determine the questionnaire's sensitivity to change in clinical health status in these patients.
  OUTLINE: Patients are stratified according to type of treatment (potentially curative vs potentially palliative), disease stage (local and locoregional vs metastatic), Karnofsky performance status (less than 80% vs more than 80%), and initial weight gain (none vs less than 10% of total body weight vs 10% or more of total body weight).
  -  Curatively Treated Group: Quality of life is assessed at 4 weeks prior to surgery and 3 months after surgery in patients receiving total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy, 4 weeks prior to surgery, and 3 months after surgery in patients receiving neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent; at 4 weeks prior to chemotherapy and/or radiotherapy and 6 weeks after completion of therapy in patients receiving adjuvant chemotherapy and/or radiotherapy following total or partial gastrectomy; and at 4 weeks prior to therapy and 3 months after completion of therapy in patients receiving endoscopic mucosal resection or laparoscopic wedge resection.
  -  Palliatively Treated Group: Quality of life is assessed at 3 weeks prior to palliative therapy and 4 weeks after beginning palliative therapy.
  PROJECTED ACCRUAL: Approximately 220 patients (110 per group) will be accrued for this study within 2 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed gastric adenocarcinoma
  -  Patients treated with curative intent according to one of the following criteria:
  -  Plan to undergo total or partial gastrectomy with curative intent
  -  Plan to receive neoadjuvant chemotherapy and/or radiotherapy followed by total or partial gastrectomy with curative intent
  -  Prior total or partial gastrectomy with curative intent and currently receiving adjuvant chemotherapy and/or radiotherapy
  -  Prior endoscopic mucosal resection or laparoscopic wedge resection of early gastric cancer OR
  -  Patients with initial diagnosis of gastric cancer or recurrent disease with plans to receive one of the following therapies with palliative intent:
  -  Total or partial gastrectomy or bypass procedure
  -  Endoscopic procedure (e.g., stent insertion)
  -  Chemotherapy and/or radiotherapy
  -  Supportive measures only
  -  No concurrent enrollment on other quality of life study that would interfere with this study
  -  Not previously enrolled on this study
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Performance status:
  -  Any performance status
  Life expectancy:
  -  At least 2 months for patients treated with curative intent
  -  At least 4 weeks for patients treated with palliative intent
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  No other concurrent malignancies except basal cell carcinoma of the skin
  -  No mental impairment that would preclude completion of questionnaire
  -  No psychological, familial, sociological, or geographical condition that would preclude study compliance
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  See Disease Characteristics
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  See Disease Characteristics
  Surgery:
  -  See Disease Characteristics

Relevance to patient case: not relevant