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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00454376
Other study ID # CDR0000537344
Secondary ID EORTC-QLQ-G.I.NE
Status Active, not recruiting
Phase Phase 4
First received March 27, 2007
Last updated October 28, 2013
Start date October 2006

Study information

Verified date November 2008
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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 neuroendocrine tumors.

PURPOSE: This phase IV clinical trial is studying how well a disease-specific questionnaire works in assessing the quality of life of patients with gastrointestinal-related neuroendocrine tumors.


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 tumors.

Secondary

- Determine the quality of life of patients using QLQ-C30 and the QLQ-G.I.NET21 before and after treatment.

OUTLINE: This is a multicenter study. Patients are stratified according to treatment (somatostatin analogue therapy or interferon therapy vs radionuclide therapy or chemotherapy vs ablative therapies [embolization or radiofrequency ablation] or liver resection).

Patients complete the EORTC C30 questionnaire, QLQ-G.I.NET21 module, and are evaluated for Karnofsky performance status at pretreatment, at 3 and 6 months after treatment, and then 2 weeks later. Patients also complete a clinical data and sociodemographic data form and debriefing questionnaire at pretreatment; a follow-up form at 3 months and 6 months after treatment; and a test-retest form 2 weeks later.

PROJECTED ACCRUAL: A total of 408 patients will be accrued for this study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 408
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

N/A


Intervention

Other:
questionnaire administration

Procedure:
quality-of-life assessment


Locations

Country Name City State
Denmark Aarhus Universitetshospital - Aarhus Sygehus Aarhus
Germany Charite - Campus Charite Mitte Berlin
Germany Klinikum der Universitaet Regensburg Regensburg
Greece University Athens Alexandras Hospital Athens
Israel Hadassah University Hospital Jerusalem
Italy Clinical and Experimental Medicine at the University of Verona Verona
Netherlands Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Amsterdam
Poland Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology - Warsaw Warsaw
Spain Hospital Universitario San Carlos Madrid
Sweden Uppsala University Hospital Uppsala
United Kingdom Basingstoke and North Hampshire NHS Foundation Trust Basingstoke England
United Kingdom Royal Victoria Hospital Belfast Northern Ireland
United Kingdom Aintree University Hospital Liverpool England
United Kingdom King's College Hospital London England
United Kingdom UCL Cancer Institute London England
United Kingdom Southampton General Hospital Southampton England

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

Denmark,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21) No
Secondary Response to change after various treatments No
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