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Home > "A" Clinical Trials Conditions > Assessing Quality of Life of Patients With Stomach Cancer  Assessing Quality of Life of Patients With Stomach Cancer
Assessing Quality of Life of Patients With Stomach Cancer
For Condition: adenocarcinoma of the stomach,Quality of Life
Status: No longer recruiting
Sponsor(s): EORTC Quality of Life Study Group , EORTC Gastrointestinal Tract Cancer Cooperative Group
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JaneBlazeby, Study Chair, Bristol Haematology and Oncology Centre
Royal Infirmary
Glasgow, Scotland, G4 0SF
United Kingdom
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
University of Marburg
Marburg, , D-35033
Germany
Universitaetsklinikum Charite
Berlin, , D-10117
Germany
Hospital De Navarra
Pamplona, , 31080
Spain
Sahlgrenska University Hospital
Gothenburg (Goteborg), , S-413 45
Sweden
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
United Kingdom
Additional Information:
Study ID Numbers: CDR0000068717; EORTC-40003,EORTC-15001
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020826
Other Quality Of Life Studies:
1. Quality-of-Life Assessment in Patients With Ovarian Cancer
2. PNU-93914 in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
3. Biafine Cream to Reduce Side Effects of Radiation Therapy in Patients Receiving Treatment for Head and Neck Cancer
4. Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
5. Topotecan in Treating Patients With Relapsed Small Cell Lung Cancer
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Assessing Quality of Life of Patients With Stomach Cancer
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