Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT02857699 Statut inconnu

Titre

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. (QoL Phase I)

Type

Observational

Pathologie

Phase

Promoteur

Institut Curie (Voir sur ClinicalTrials)

Date de début

avril 2014

Date de fin

juin 2017

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail The main objective of phase I dose finding studies is to identify the recommended phase II dose. The primary endpoint is the dose limiting toxicity (DLT) which is generally measured using the NCI common toxicity criteria (NCI-CTCAE) graded scale. This scale, developed for the investigation of cytotoxic chemotherapy administered in a limited number of cycles including rest period, is well adapted to identify the drug effect on organ dysfunction and life threatening events. However it may be less relevant to reflect the patient's feeling regarding the tolerability of the treatment under study resulting in over or under estimation of these toxicities. 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CLCC INSTITUT CURIE	En recrutement IDF	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Claudius Regaud - Toulouse - France	En recrutement	Contact (sur clinicalTrials)
Centre Georges Francois Leclerc - Dijon - France	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- 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.

Critère de non inclusion

- 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.

NCT02857699 - 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. (QoL Phase I)

Informations générales
Etablissements
Critères
Accès à la fiche NCT

Retour en haut