Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation (MUMOFRAT)

Multiscale Modeling / Simulation of the Response to Pulmonary Stereotactic Hypofractionated Irradiation

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

Study Overview

• Status: Unknown
• Conditions: Oncology
• Intervention / Treatment: Other: Stereotactic radiotherapy

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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Ulrike Schick, Doctor; Phone Number: +33 0298223398; Email: ulrike.schick@chu-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHRU de Brest
    • Contact: Ulrike Schick, Doctor; Phone Number: +33 0298223398; Email: ulrike.schick@chu-brest.fr
  • Rennes, France, 35042
    • Recruiting
    • Centre Eugene Marquis
    • Contact: Enrique Chajon; Phone Number: +33(0)2 99 25 30 92; Email: e.chajon@rennes.unicancer.fr
  • Saint-Herblain, France, 44805
    • Recruiting
    • Institut de Cancérologie de l'Ouest
    • Contact: Marc André Mahé; Phone Number: +33(0)2 40 67 99 00; Email: marc-andre.mahe@ico.unicancer.fr
  • Tours, France, 37000
    • Completed
    • Clinique d'Oncologie et Radiothérapie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All major patients requiring stereotactic radiotherapy for non-small cell bronchopulmonary carcinoma.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetics of PET-CT parameters : standardized uptake value (SUV) max	SUV max will be measured before and after stereotactic irradiation.	2 years
Tumor metabolic response	Tumor metabolic response, as assessed on 18F-FDG PET-CT at 6 months of end of radiotherapy	2 years
Local control	Local control defined by the absence of progression in the irradiated area	2 years
Kinetics of PET-CT parameters : metabolic tumor volume	Metabolic tumor volume (MTV) will be measured before and after stereotactic irradiation.	2 years
Kinetics of PET-CT parameters : texture parameters :quantitative extraction of images by specific software	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinetics of serum markers	The kinectic will be measured	2 years
Predictive power of serum markers for tumor response and local control	This predictive power will be measured	2 years
Predictive power of metabolic imaging parameters for tumor response and local control Predictive power of metabolic imaging parameters for tumor response and local control	This predictive power will be measured	2 years
Correlation between these parameters	The correlation will be measured	2 years
Survival in disease	The survival in desease will be observed	2 years
Survival without metastasis at a distance	The survival without metastasis will be observed	2 years
Radiation-induced toxicity	The radiation-induced toxicity will be observed	2 years

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Ulrike Schick, Doctor, University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: MUMOFRAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No