Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation

Oncology Clinical Trial

— MUMOFRAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03175861
• Other study ID #: MUMOFRAT
• Status: Recruiting
• Start date: June 14, 2017
• Est. completion date: June 2020

Study information

• Verified date: October 2018
• Source: University Hospital, Brest
• Contact: Ulrike Schick, Doctor
• Phone: 0298223398
• Email: ulrike.schick[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oncology

Intervention

Other:
• Stereotactic radiotherapy
The patient will have an initial pre-therapeutic assessment in the 8 weeks before the start of radiotherapy Then, radiation therapy planning with 3 free breathing 4D (4 dimensions) scanners performed over 8 days without injection of iodinated contrast agent. Then the patient will receive his treatment by conventional stereotactic radiotherapy

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinetics of PET-CT parameters : standardized uptake value (SUV) max	SUV max will be measured before and after stereotactic irradiation.	2 years
Primary	Tumor metabolic response	Tumor metabolic response, as assessed on 18F-FDG PET-CT at 6 months of end of radiotherapy	2 years
Primary	Local control	Local control defined by the absence of progression in the irradiated area	2 years
Primary	Kinetics of PET-CT parameters : metabolic tumor volume	Metabolic tumor volume (MTV) will be measured before and after stereotactic irradiation.	2 years
Primary	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	Kinetics of serum markers	The kinectic will be measured	2 years
Secondary	Predictive power of serum markers for tumor response and local control	This predictive power will be measured	2 years
Secondary	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
Secondary	Correlation between these parameters	The correlation will be measured	2 years
Secondary	Survival in disease	The survival in desease will be observed	2 years
Secondary	Survival without metastasis at a distance	The survival without metastasis will be observed	2 years
Secondary	Radiation-induced toxicity	The radiation-induced toxicity will be observed	2 years