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Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (Lungevity Study)

ConditionsMetastatic Lung CancerMetastatic NSCLCMetastatic Small Cell Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGFPC Investigation

About this trial

The goal of this observational study is to identify and describe the clinical characteristics, health status, socio-economic impacts and quality of life of patients alive for three years after diagnosis of metastatic Lung cancer and no longer receiving cytotoxic chemotherapy. The main question is to identify the needs of these patients in terms of health status (impact of cancer treatments, incidence of new diseases, cardiovascular, diabetes, second cancers), socio-economic aspects, quality of life and return to employment.

Participants will be asked to answer quality of life questionnaires at the time of inclusion and 6 and 12 months after inclusion and then, every year up to 5 years in this study.

They will be followed regularly, in consultations, according to the usual practices of the physicians in each participating center.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient over 18 years old

Patients alive after more than three years from diagnosis with stage IV or Stage III NSCLC or SCLC, not treated with cytotoxic chemotherapy at the time of inclusion (the patient may be undergoing imunotherapy, targeted therapy or surveillance).

Patients covered by the French National Health Insurance program or with thirdparty-payer health insurance

Disqualifiers

Difficulties for understanding French

Patients undergoing treatment with cytotoxic chemotherapy

Patients under legal guardianship, under curatorship or tutorship

Insufficient cognitive capacity to answer questions

Trial population

Patients will be recruited by GFPC centers which is a large French network of hospitals and clinics particularly active in pneumology and thoracic oncology centers participating in clinical research. The principal investigator in each center will identify consecutive patients eligible for inclusion. Patients will be asked to confirm their consent for data collection.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hospital Anxiety and Depression scale (HAD)

    Behavioral

    The HAD scale is an instrument used to screen for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven others to depression (total D), giving two scores (maximum score for each = 21).

  • Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13)

    Behavioral

    The EORTC QLQ-LC13: a 13-item lung cancer-specific questionnaire module supplement to the EORTC core quality of life questionnaire (QLQ-C30) for use in lung cancer clinical trials. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (cough, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

  • Questionnaire Aix-Marseille-Université (AMU)

    Behavioral

    Data analysis will be firstly descriptive in order to report on the quality of life of respondents. Then, in a second stage, the factors associated with quality of life will be analyzed using linear or logistic regression models depending on the nature of the variable of interest.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: Long-Terms Responders in metastatic Lung Cancer3 interventions

Trial outcomes

Primary outcomes

1

Baseline Clinical Characteristics

Metastatic Lung Cancer Long-Terms Responders clinical characteristics: baseline patient demographics, clinical and pathological characteristics (e.g. age, medical history, comorbidities, past history of cancer, smoking status, NSCLC or SCLC characteristics)

Time frame
At Baseline visit, on a maximum period of 12 months.
2

Aix-Marseille-University (AMU) questionnaire

Time frame
At inclusion, 6 and 12 months after inclusion and every year up to 5 years
3

EORTC QLQ-LC13

Time frame
at inclusion, 6 and 12 months after inclusion and every year up to 5 years
4

Hospital Anxiety and Depression Scale (HAD)

Time frame
at inclusion, 6 and 12 months after inclusion and every year up to 5 years

Secondary outcomes

1

Progression free survival (PFS)

PFS is defined as the length of time during and after the treatment of cancer, that a patient lives with the disease but it does not get worse. PFS will be assessed by local review, as per the current practice at site.

Time frame
From date of first lung cancer treatment administration up to 5 years
2

Overall Survival (OS)

Overall Survival is defined as the length of time from the start of treatment for the cancer that patients diagnosed with the disease are still alive.

Time frame
From date of first lung cancer treatment initiation up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GFPC Investigation

Lead sponsor

Source ClinicalTrials.gov
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