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.

Condition	Treatment or Intervention
adenocarcinoma of the stomach Quality of Life	Procedure: quality-of-life assessment  Procedure: supportive care/therapy

Further Study Details: 

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.

Genders Eligible for Study:  Both

Criteria

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

France
      Centre Alexis Vautrin, Vandoeuvre-les-Nancy,  54511,  France
Germany
      Universitaetsklinikum Charite, Berlin,  D-10117,  Germany
      University of Marburg, Marburg,  D-35033,  Germany
Spain
      Hospital De Navarra, Pamplona,  31080,  Spain
Sweden
      Sahlgrenska University Hospital, Gothenburg (Goteborg),  S-413 45,  Sweden
United Kingdom, England
      Bristol Haematology and Oncology Centre, Bristol,  England,  BS2 8ED,  United Kingdom
United Kingdom, Scotland
      Royal Infirmary, Glasgow,  Scotland,  G4 0SF,  United Kingdom

Study chairs or principal investigators

Jane Blazeby, MB, CHB, FRCS, BSc, MD,  Study Chair,  Bristol Haematology and Oncology Centre   
Thierry Conroy, MD,  Study Chair,  Centre Alexis Vautrin   

Study ID Numbers:  CDR0000068717; EORTC-15001; EORTC-40003
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020826
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08