Status:
UNKNOWN
Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Gastrointestinal Carcinoid Tumor
Islet Cell Tumor
Eligibility:
All Genders
18+ years
Brief Summary
RATIONALE: Questionnaires that measure quality of life may help doctors identify the effects of treatment and improve the ability to plan treatment for patients with gastrointestinal-related neuroendo...
Detailed Description
OBJECTIVES: Primary * Test the scale structure, reliability, and validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) in patients with gastrointestinal-related neuroendocrine...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed neuroendocrine tumor OR characteristic radiological findings of neuroendocrine tumor with raised hormone levels in plasma or urine meeting any of the following criteria:
- Primary disease in gut with liver metastases (with or without hormone secretion)
- Primary disease in lung with liver or abdominal metastases (with or without hormone secretion)
- Primary disease in pancreas with or without metastases (with or without hormone secretion)
- PATIENT CHARACTERISTICS:
- Any Karnofsky performance status allowed
- Life expectancy ≥ 3 months
- Able to understand the questionnaire language
- Mentally fit to complete questionnaire
- No psychological, familial, sociological, or geographical condition that would limit study compliance
- No other concurrent malignancies except basal cell carcinoma of the skin
- PRIOR CONCURRENT THERAPY:
- More than 2 months since prior somatostatin analogue or interferon therapy (somatostatin therapy stratum)
- Concurrent somatostatin analogue and/or interferon therapy allowed if dose stable over the past month
- More than 6 months since prior radionuclide therapy or systemic chemotherapy (radionuclide or systemic chemotherapy stratum)
- More than 6 months since prior ablative therapies (ablative therapy stratum)
- No concurrent participation in other quality of life studies
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00454376
Start Date
October 1 2006
Last Update
October 29 2013
Active Locations (16)
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1
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, Denmark, DK 8000
2
Charite - Campus Charite Mitte
Berlin, Germany, D-10117
3
Klinikum der Universitaet Regensburg
Regensburg, Germany, D-93053
4
University Athens Alexandras Hospital
Athens, Greece, 611