Clinical trial NCT03175861: Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation
Official title: Multiscale Modeling / Simulation of the Response to Pulmonary Stereotactic Hypofractionated Irradiation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oncology
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All major patients requiring stereotactic radiotherapy for non-small cell bronchopulmonary carcinoma.

Brief summary: Identify 18-Fluorodeoxyglucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) parameters predictive of tumor response and local control

Detailed description: The identification of robust prognostic and predictive markers could allow the individualization of pulmonary stereotactic radiotherapy treatments and the selection of patients at high risk of relapse, who could then benefit from a dose escalation in order to increase the chances of local control .

Beyond the pulmonary RTS (Radiotherapy in stereotactic condition), this study will aim to generate one or more models of multi-scale response to hypofractionated irradiation from biomarkers (biological or images) extracted from preclinical or clinical literature data and to allow simulations of Various modified fractionation irradiation schemes, potentially leading to new regimens that reduce side effects and increase therapeutic efficacy.

Eligibility criteria: Inclusion Criteria:

* Age\> 18 years
* Performance Index WHO (World Health Organization) ≤ 2
* Bronchopulmonary carcinoma not in small cells proved histologically or cytologically (epidermoid, adenocarcinoma, or large cell carcinoma).
* Tumor classified T1 - T2 (Tumor=1-2) N0 (Node=0) M0 (Metastasis=0) and diameter ≤ 5 cm or Tumor classified T3 (≤5cm) N0M0 of the chest wall
* Tumor located more than 2 cm from the trachea and bronchus stem and more than 1.5 cm from the organs at risk
* Medically inoperable or refusing surgery
* Indication of stereotactic radiotherapy validated in multidisciplinary consultation meeting
* Formulation of consent

Exclusion Criteria:

* Age \<18 years.
* History of pulmonary irradiation
* Pulmonary surgery of the tumor
* Different histology of non-small cell carcinoma
* Patient with a T2 or T3\> 5 cm tumor or patients with a T3 tumor invading a structure other than the chest wall
* Patient with a tumor within 2 cm of the trachea and bronchus stem and within 1.5 cm of the organs at risk in the proximal area of the no fly zone (defined as a volume Located 2 cm in all directions of the proximal bronchial tree - Pulmonary metastases
* Declared pregnancy, breast-feeding
* Refusal to use effective contraception
* Against indication to the realization of the PET to the 18FDG (18-fluorodeoxyglucose)(uncontrolled diabetes)
* Refusal or inability to consent to participate in the study.
* Estimated life expectancy \<2 months in the absence of treatment
* Other invasive tumors diagnosed in the previous 2 years, with the exception of non-melanocytic cutaneous carcinomas.

Primary outcomes:
measure: Kinetics of PET-CT parameters : standardized uptake value (SUV) max
timeFrame: 2 years
measure: Tumor metabolic response
timeFrame: 2 years
measure: Local control
timeFrame: 2 years
measure: Kinetics of PET-CT parameters : metabolic tumor volume
timeFrame: 2 years
measure: Kinetics of PET-CT parameters : texture parameters :quantitative extraction of images by specific software
timeFrame: 2 years
Secondary outcomes:
measure: Kinetics of serum markers
timeFrame: 2 years
measure: Predictive power of serum markers for tumor response and local control
timeFrame: 2 years
measure: Predictive power of metabolic imaging parameters for tumor response and local control Predictive power of metabolic imaging parameters for tumor response and local control
timeFrame: 2 years
measure: Correlation between these parameters
timeFrame: 2 years
measure: Survival in disease
timeFrame: 2 years
measure: Survival without metastasis at a distance
timeFrame: 2 years
measure: Radiation-induced toxicity
timeFrame: 2 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
city: Tours
country: France
facility: Clinique d'Oncologie et Radiothérapie
Study officials:
affiliation: University Hospital, Brest
name: Ulrike Schick, Doctor
role: PRINCIPAL_INVESTIGATOR
References: