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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00020826 |
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Date of registration:
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11/07/2001 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessing Quality of Life of Patients With Stomach Cancer
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Scientific title:
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An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (The QLQ-STO22) In Assessing The Quality Of Life Of Patients With Gastric Cancer |
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Date of first enrolment:
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April 2001 |
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Target sample size:
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267 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00020826 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Germany
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Spain
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Sweden
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United Kingdom
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Contacts
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Name:
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Thierry Conroy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Alexis Vautrin |
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Name:
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Jane Blazeby, MB, CHB, FRCS, BSc, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospitals Bristol NHS Foundation Trust |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastric Cancer
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Intervention(s)
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Other: quality-of-life assessment
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Primary Outcome(s)
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psychometric validity of the STO22 module
[Time Frame: The EORTC QLQ-C30 and the gastric cancer module (QLQ-STO22) will be prospectively administered once before and once after primary treatment.]
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Secondary Outcome(s)
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debriefing questionnaire information
[Time Frame: at baseline]
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Secondary ID(s)
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EORTC-15001
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EORTC-15001-40003
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EORTC-40003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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