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.
NCT ID: NCT02857699
Last Updated: 2016-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2014-04-30
2017-06-30
Brief Summary
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Patients from trials investigating chemotherapy alone will not be included. Quality of life will be assessed during the treatment period.
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Detailed Description
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Moreover, targeted therapies and more specifically the ones administered orally are given over long periods often with continuous schedules. Moderate toxic side effects lasting over a long period are usually not considered as DLT. The health related quality of life of patients as well as other patient reported outcome including symptom scale in addition to usual NCI CTCAE scale could be a relevant variable to detect intolerable treatments. It has not been studied prospectively to date in phase I trials.
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.
Patients included in a phase I trial will be requested to fill in
* a questionnaire of health related quality of life (the EORTC PAL 15 questionnaire)
* a questionnaire of symptoms (MDASI)
* a questionnaire on symptoms specific of MTA at baseline and at each cycle of treatment and 6 weeks after the end of treatment.
The sponsor of the therapeutic phase I trials will be informed that the present research is running and that it will not interfere with their investigational protocol. Each phase I center has the latitude to propose or not the health-related quality of life research to patients included in a given phase I trial.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patient included in a dose finding phase I trial investigating at least one molecularly targeted agent as defined as anticancer agents that selectively target molecular pathways (including monoclonal antibodies) as opposed to DNA, tubulin or cell division machinery will be eligible.
* Phase I/II clinical trials with a dose finding component are also eligible. Trials investigating combinations of MTA with one or several cytotoxic agent(s) are eligible, as well as combinations of MTAs.
Exclusion Criteria
Patients included in the following types of phase I trials are not eligible:
* Trials investigating hormonal therapy and biological therapeutics such as immunotherapy, gene therapy and vaccines alone or in combination;
* Trials of cytotoxic agents only;
* Trials investigating radiochemotherapy alone or in combination with chemotherapy or MTA
* Trials whose objectives do not include dose-finding. This includes pharmacokinetic only trials, bioequivalence trials, feasibility trials etc.
ALL
No
Sponsors
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Centre Georges Francois Leclerc
OTHER
Institut Curie
OTHER
Responsible Party
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Principal Investigators
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Xavier PAOLETTI, PhD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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Centre Georges Francois Leclerc
Dijon, , France
Institut Curie
Paris, , France
Centre Claudius Regaud
Toulouse, , France
Countries
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Central Contacts
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Other Identifiers
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IC 2013-07
Identifier Type: -
Identifier Source: org_study_id
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