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

Weprom

Status and phase: Completed; Phase 3

Conditions: Lung Cancer

Treatments: Other: Monitoring by SENTINEL application

Study type: Interventional

Funder types: Other

Identifiers

NCT02361099

2014-A00263-44 (Other Identifier)

WP-2018-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 2 patient groups

Monitoring by SENTINEL application

Experimental group

Description:

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.

Treatment:

Other: Monitoring by SENTINEL application

Conventional Monitoring

No Intervention group

Description:

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