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Center for Global Research Data

Comparison of the EORTC QLU-C10D with generic utility instruments and development of a comprehensive manual for its use

Lead Investigator: Eva-Maria Gamper, Medical University Innsbruck
Title of Proposal Research: Comparison of the EORTC QLU-C10D with generic utility instruments and development of a comprehensive manual for its use
Vivli Data Request: 4926
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

The QLU-C10D is a newly developed, cancer-specific multi-attribute utility instrument which has been included in the EORTC (European Organisation for Research and Treatment of Cancer) assessment system and can be used to obtain health utilities for use in economic evalations. The most commonly used utility instruments are generic, i.e. cover overall aspects of health only. The QLU-C10D is based on the QLQ-C30, one of the most widely used quality of life instruments in oncology research. Ten of its 15 domains were selected in a thorough process to be used in the QLU-C10D, including cancer-specific issues, such as fatigue and nausea. Therefore, it may be more sensitive to health state differences and changes in cancer patients’ than generic measures. To investigate this, in addition to our own prospective data collection, we also retrieve data from existing trials which used both, the QLQ-C30 and other generic utility instrument. We will retrospectively calculate QLU-C10D utilities to compare them to utilites obtained from the generic instrument with regard to sensitivity and responsiveness using clinical known groups and health changes over time as defined in the respective trial (e.g. treatment response groups, performance status, treatment arms, etc.)

Requested Studies:

A Randomised, Open-label, Phase III Study of BIBW 2992 Versus Chemotherapy as First-line Treatment for Patients With Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation
Sponsor: Boehringer Ingelheim
Study ID: NCT00949650
Sponsor ID: 1200.32

LUX-Lung 8: A Randomized, Open-label Phase III Trial of Afatinib Versus Erlotinib in Patients With Advanced Squamous Cell Carcinoma of the Lung as Second-line Therapy Following First-line Platinum-based Chemotherapy
Sponsor: Boehringer Ingelheim
Study ID: NCT01523587
Sponsor ID: 1200.125

Phase IIb/III Randomized, Double-blind Trial of BIBW 2992 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-Lung 1)
Sponsor: Boehringer Ingelheim
Study ID: NCT00656136
Sponsor ID: 1200.23

Phase III Randomized Trial of BIBW 2992 Plus Weekly Paclitaxel Versus Investigator’s Choice of Chemotherapy Following BIBW 2992 Monotherapy in Non-small Cell Lung Cancer Patients Failing Previous Erlotinib or Gefitinib Treatment (LUX Lung 5)
Sponsor: Boehringer Ingelheim
Study ID: NCT01085136
Sponsor ID: 1200.42