Prospective Observational Study to Investigate the Added Value of the Health Related Quality of Life and Patient Reported Symptoms in the Identification of the Recommended Phase II Dose in Phase I Trials of Molecularly Targeted Therapies.
NCT02857699 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 250
Last updated 2016-08-05
Summary
A prospective cohort of 250 patients with solid tumours included in phase I clinical trials of targeted agents will be enrolled. Patients will be treated with MTA in mono therapy or in association with chemotherapy or other targeted agents in 4 large phase I centers.
Patients from trials investigating chemotherapy alone will not be included. Quality of life will be assessed during the treatment period.
Conditions
- Solid Tumors
- Quality of Life
Sponsors & Collaborators
-
Centre Georges Francois Leclerc
collaborator OTHER -
Institut Curie
lead OTHER
Principal Investigators
-
Xavier PAOLETTI, PhD · Gustave Roussy, Cancer Campus, Grand Paris
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-04-30
- Primary Completion
- 2017-06-30
- Completion
- 2017-06-30
Countries
- France
Study Locations
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