SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse

Lung Cancer Clinical Trial

— SENTINEL  

Official title:

Phase 3 Multicentric Randomized Study Assessing Self-reported Symptoms Transmitted Via an Internet Web-application " Sentinel " Versus Conventional Follow-up in Patients With High Risk Lung Cancer (SENTINEL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361099
• Other study ID #: WP-2018-01
• Secondary ID: 2014-A00263-44
• Status: Completed
• Phase: Phase 3
• Start date: June 3, 2014
• Est. completion date: March 2018

Study information

• Verified date: January 2018
• Source: Weprom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

With a 5-year survival of about 15% pulmonary cancer is very poor prognosis. About 70 to 75% of cancers are diagnosed at advanced stages. Relapses are common and rarely curable. At least 75% of relapses are symptomatic and there is no standard monitoring after curative treatment or not. Currently, the most common monitoring strategy involves the completion of a clinical examination every 3 to 6 months associated with chest X-ray or CT-scan.

An intensive clinical and imaging monitoring has not yet shown any survival advantage but monitoring of symptoms appears to have a significant medical and economic advantage compared to imaging monitoring. This non-personalized approach is a source of anxiety for patients, especially with the approach of the date of the imaging assessment. In contrast, this monitoring can leave symptomatic patients with untreated relapse for several weeks because many symptomatic patients wait the date of the imaging assessment to consult.

the investigators have developed a score based on the dynamics and the association of clinical signs to alert the physician to a possible recurrence of lung cancer. The referring physician is alerted so early and convenes the patient for a checkup. One of the explanations which could demonstrate the gain in survival is the possibility offered by the application SENTINEL is to treat the relapses earlier, thus avoiding to wait a too much important deterioration of general condition between two monitoring follow-up more or less spaced.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient with lung cancer (NSCLC and SCLC), histologically proven

2. Patient at high risk of relapse (TxN1, IIIA, IIIB, IV stages)

3. Age = 18 ans

4. PS = 2 within 15 days before enrollment

5. 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

• 1st 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.

6. Patient with an initial SENTINEL score = 6

7. Patient with internet access and an e-mail box

8. Patient affiliated to a social security scheme

9. Patient has given its written consent before any specific procedure from protocol

Exclusion Criteria:

1. Patient whose disease has progressed at the end of the specific treatment

2. Symptomatic brain metastases

3. Persons deprived of liberty or under guardianship or curators

4. 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

5. Patient who cannot submit himself to the followed of the protocol for psychological reasons, social, family or geographical

6. Pregnant or breastfeeding women

7. Patient participating in another interventional study

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Monitoring by SENTINEL application
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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Angers
France	Institut de Cancerologie de l'Ouest - site Paul Papin	Angers
France	Institut Sainte Catherine	Avignon
France	Centre Hospitalier Général	Chartres
France	Centre Hospitalier Départemenal	La Roche Sur Yon
France	Centre Hospitalier	Le Mans
France	Centre Jean Bernard	Le Mans
France	Centre Catherine de Sienne	Nantes
France	Institut de Cancerologie de l'Ouest - site René Gauducheau	Saint Herblain

Sponsors (2)

Lead Sponsor	Collaborator
Weprom	SIVAN Innovation Ldt

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life (QOL)	The quality of life will be studied using the questionnaire FACT-L at baseline and follow-up visits at 3, 6 and 12 months.	12 month
Secondary	Depression	Patient's depression will be assessed through the questionnaire HUMEUR PHQ9 at baseline and follow-ups at 3, 6 and 12 months.	12 month
Secondary	Relapse detection time	The relapse detection time is defined as time from the date of diagnosis to the date of highlighting of the recurrence by imaging	24 month
Secondary	Performance Status (PS)	Performance Status will be evaluated according to WHO recommendations.	24 month
Secondary	Cost of monitoring	The cost of monitoring will be evaluated from the perspective of health insurance.	24 month
Secondary	Patient compliance	Patient compliance to the use of SENTINEL application will be evaluated according to the number of assessments completed (usually 1 per week) compared to the theoretical maximum number filling weekly and monthly the application over time.	24 month