Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation
- Conditions
- Oncology
- Registration Number
- NCT03175861
- Lead Sponsor
- University Hospital, Brest
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Kinetics of PET-CT parameters : metabolic tumor volume 2 years Metabolic tumor volume (MTV) will be measured before and after stereotactic irradiation.
Local control 2 years Local control defined by the absence of progression in the irradiated area
Kinetics of PET-CT parameters : standardized uptake value (SUV) max 2 years SUV max will be measured before and after stereotactic irradiation.
Tumor metabolic response 2 years Tumor metabolic response, as assessed on 18F-FDG PET-CT at 6 months of end of radiotherapy
Kinetics of PET-CT parameters : texture parameters :quantitative extraction of images by specific software 2 years The first-order form parameters and statistical parameters, the second order (based on the matrix of co-occurrence of the grey levels and the matrix of differences of grey levels) and of the third order (based on the matrices of alignment of the grey levels and the matrices of sizes of zones) will be studied.
- Secondary Outcome Measures
Name Time Method Predictive power of metabolic imaging parameters for tumor response and local control Predictive power of metabolic imaging parameters for tumor response and local control 2 years This predictive power will be measured
Survival in disease 2 years The survival in desease will be observed
Predictive power of serum markers for tumor response and local control 2 years This predictive power will be measured
Survival without metastasis at a distance 2 years The survival without metastasis will be observed
Kinetics of serum markers 2 years The kinectic will be measured
Radiation-induced toxicity 2 years The radiation-induced toxicity will be observed
Correlation between these parameters 2 years The correlation will be measured
Trial Locations
- Locations (4)
CHRU de Brest
🇫🇷Brest, France
Centre Eugène Marquis
🇫🇷Rennes, France
Institut de Cancérologie de l'Ouest
🇫🇷Saint-Herblain, France
Clinique d'Oncologie et Radiothérapie
🇫🇷Tours, France