NCT02361099

Brief Summary

This is a study that evaluates an optimization of the monitoring of patients with lung cancer in order to extend the survival of patients by improving their quality of life and decreasing anxiety generated by the achievement of balance sheets imaging. The spacing of the follow-up imaging also helps to reduce the cost of such monitoring. The main objective of this study is to evaluate the overall survival of patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at below P25 for phase_3 lung-cancer

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

June 29, 2020

Status Verified

January 1, 2018

Enrollment Period

3.5 years

First QC Date

February 3, 2015

Last Update Submit

June 25, 2020

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Overall survival is defined as the period between the date of randomization to the date of death from any cause. We will also evaluate in this context the overall survival defined between the date of diagnosis and date of death whatever the cause in order to know more precisely the duration of the disease.

    24 months

Secondary Outcomes (6)

  • Quality of Life (QOL)

    12 month

  • Depression

    12 month

  • Relapse detection time

    24 month

  • Performance Status (PS)

    24 month

  • Cost of monitoring

    24 month

  • +1 more secondary outcomes

Study Arms (2)

Monitoring by SENTINEL application

EXPERIMENTAL

Patients randomized to this arm will connect once a week to SENTINEL application to do a self-evaluation of several symptoms. A CT- scan will be scheduled only when there is an alert of the application.

Other: Monitoring by SENTINEL application

Conventional Monitoring

NO INTERVENTION

Patients randomized to this arm will have a CT-scan every 3 months.

Interventions

Monitoring by SENTINEL applicationOTHER

Patients will connect once a week to SENTINEL application to do a self-evaluation of several symptoms. A CT- scan will be scheduled only when there is an alert of the application

Also known as: new technology
Monitoring by SENTINEL application

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with lung cancer (NSCLC and SCLC), histologically proven
  • Patient at high risk of relapse (TxN1, IIIA, IIIB, IV stages)
  • Age ≥ 18 ans
  • PS ≤ 2 within 15 days before enrollment
  • Patient having:
  • finished his cancer treatment in the last 3 months by:
  • Surgery or
  • Surgery then adjuvant chemotherapy or
  • Concomitant radio-chemotherapy or
  • Conventional or stereotactic radiotherapy or
  • st or 2nd line chemotherapy
  • treatment with TKI (tyrosine kinase inhibitor) in 1st or 2nd line or maintenance treatment with Alimta® and / or Avastin® or Gemzar® well tolerated (SENTINEL 's score with this treatment (TKI or maintenance) to its latest assessment.
  • Patient with an initial SENTINEL score ≤ 6
  • Patient with internet access and an e-mail box
  • Patient affiliated to a social security scheme
  • +1 more criteria

You may not qualify if:

  • Patient whose disease has progressed at the end of the specific treatment
  • Symptomatic brain metastases
  • Persons deprived of liberty or under guardianship or curators
  • Dementia, mental alteration or psychiatric pathology that can compromise informed consent from the patient and / or adherence to the protocol and the monitoring of the trial
  • Patient who cannot submit himself to the followed of the protocol for psychological reasons, social, family or geographical
  • Pregnant or breastfeeding women
  • Patient participating in another interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Centre Hospitalier Universitaire

Angers, 49933, France

Location

Institut de Cancerologie de l'Ouest - site Paul Papin

Angers, 49933, France

Location

Institut Sainte Catherine

Avignon, 84918, France

Location

Centre Hospitalier Général

Chartres, 28018, France

Location

Centre Hospitalier Départemenal

La Roche-sur-Yon, 85925, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Centre Hospitalier

Le Mans, 72037, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

Institut de Cancerologie de l'Ouest - site René Gauducheau

Saint-Herblain, 44805, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Fabrice DENIS, MD

    Centre Jean Bernard - LE MANS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 11, 2015

Study Start

June 3, 2014

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

June 29, 2020

Record last verified: 2018-01

Locations

FR(9)