Solid TumorsQoL Phase INCT02857699
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.
An observational study of Solid Tumors and Quality of Life, run by Institut Curie at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumors, Quality of Life
- How many people
- 250 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2014to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with refractory solid tumor included in a dose finding phase I trial investigating at least one molecularly targeted agent.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Centre Georges Francois Leclerc
Dijon
- Recruiting
Institut Curie
Paris, 75005
- Recruiting
Centre Claudius Regaud
Toulouse
About this study
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.
Read the detailed description
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.
- Conditions
- Solid Tumors, Quality of Life
- Keywords
- Quality of life, Phase I trials
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Georges Francois Leclerc
- Responsible party
- Sponsor
- Investigators
- Xavier PAOLETTI, PhD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857699
- Sponsor's protocol ID
- IC 2013-07
- Acronym
- QoL Phase I
- Status last verified
- Aug 2016
- First submitted
- 28 Jul 2016
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02857699
- Acronym / sponsor ID
- QoL Phase I / IC 2013-07
- Conditions
- Solid Tumors, Quality of Life
- Keywords
- Quality of life, Phase I trials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Collaborators
- Centre Georges Francois Leclerc
- Study start
- Apr 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 5 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with refractory solid tumor included in a dose finding phase I trial investigating at least one molecularly targeted agent.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients with malignant hematologic disease will not be 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the association between HR QoL, patient reported symptoms and DLT.
Time frame: up to six months
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
Patient interviews : qualitative comparison versus EORTC PAL 15 questionary
Time frame: Up to six months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier PAOLETTI, PhD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumors and Quality of Life, run by Institut Curie at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia TRESCA, MD (+33.1.56.24.56.30, chrystelle.gastrin@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the association between HR QoL, patient reported symptoms and DLT. (time frame: up to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2016.