Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Disease-Specific Questionnaire in Assessing Quality of Life in Patients With Gastrointestinal-Related Neuroendocrine Tumors

Basic Trial Information

Objectives

Primary

1. 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

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

Entry Criteria

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)

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

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

Expected Enrollment

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

Outcomes

Reliability, scaling, scale correlation, and clinical validity of the gastrointestinal neuroendocrine tumor module (QLQ-G.I.NET21)

Response to change after various treatments

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

John Ramage, MD, Protocol chair		Ph: 44-125-631-4793

Registry Information
Official Title		Clinical and Psychometric Validation of a Disease-Specific Questionnaire Module in Assessing the Quality of Life of Patients with G.I.-Related Neuroendocrine Tumours
Trial Start Date		2006-10-01
Registered in ClinicalTrials.gov		NCT00454376
Date Submitted to PDQ		2007-02-14
Information Last Verified		2008-11-21

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