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 | Unknown

• 1 other identifier: IC 2013-07
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Quality of life; Phase I trials

Outcome Measures

Primary Outcomes (2)

• To evaluate the association between HR QoL, patient reported symptoms and DLT.

  To evaluate whether some toxic side events that are non dose limiting according to the phase I protocol are reported as intolerable by the patients using either specific HR QoL questionnaires or patient reported scales of symptoms

  up to six months

• Patient interviews : qualitative comparison versus EORTC PAL 15 questionary

  Identify if some dimensions of the quality of life affected by the treatment are not captured by the EORTC PAL 15 questionaries. Interviews will be realized on a sub sample of patients. An explorative qualitative research could evaluate patients' experience of the impact, burden, tolerability or acceptability of phase I anti-cancer drug trials addressing patients' perception of symptoms, functioning and overall quality of life. Interviews results contrasted with the PAL15 questionnaires will enable to determine whether a QoL questionnaire dedicated to phase I trials is necessary and what are the main components felt essential to the patients.

  Up to six months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with refractory solid tumor included in a dose finding phase I trial investigating at least one molecularly targeted agent.

You may qualify if:

• Patients with refractory solid tumor.
• 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.

You may not qualify if:

• \- Patients with malignant hematologic disease will not be eligible.
• 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.

Sponsors & Collaborators

• Institut Curie: lead
• Centre Georges Francois Leclerc: collaborator

Study Sites (3)

Centre Georges Francois Leclerc

Dijon, France

RECRUITING

Institut Curie

Paris, 75005, France

RECRUITING

Centre Claudius Regaud

Toulouse, France

RECRUITING

Study Officials

• Xavier PAOLETTI, PhD

  Gustave Roussy, Cancer Campus, Grand Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia TRESCA, MD

CONTACT

+33.1.56.24.56.30; chrystelle.gastrin@curie.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 5, 2016
• Study Start: April 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 5, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)