Clinical trial NCT02361099: SENTINEL : Impact of the Use of a Web-application for the Detection of Lung Cancer Relapse
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: Weprom
Sponsor class: OTHER
Collaborators: name: Sivan Innovation Ltd.
First posted: 2015-02-11
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: 24 months
Secondary outcomes:
measure: Quality of Life (QOL)
timeFrame: 12 month
measure: Depression
timeFrame: 12 month
measure: Relapse detection time
timeFrame: 24 month
measure: Performance Status (PS)
timeFrame: 24 month
measure: Cost of monitoring
timeFrame: 24 month
measure: Patient compliance
timeFrame: 24 month
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Universitaire
city: Angers
country: France
facility: Institut de Cancerologie de l'Ouest - site Paul Papin
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Chartres
country: France
facility: Centre Hospitalier Général
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Départemenal
city: Le Mans
country: France
facility: Centre Jean Bernard
city: Le Mans
country: France
facility: Centre Hospitalier
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Saint Herblain
country: France
facility: Institut de Cancerologie de l'Ouest - site René Gauducheau
Study officials:
affiliation: Centre Jean Bernard - LE MANS
name: Fabrice DENIS, MD
role: PRINCIPAL_INVESTIGATOR
References: