Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation

NCT03175861 | Unknown

• 1 other identifier: MUMOFRAT
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Oncology

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Kinetics of serum markers

  2 years

• Predictive power of serum markers for tumor response and local control

  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

  2 years

• Correlation between these parameters

  2 years

• Survival in disease

  2 years

Interventions

Stereotactic radiotherapy OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (4)

CHRU de Brest

Brest, 29609, France

RECRUITING

Centre Eugène Marquis

Rennes, 35042, France

RECRUITING

Institut de Cancérologie de l'Ouest

Saint-Herblain, 44805, France

RECRUITING

Clinique d'Oncologie et Radiothérapie

Tours, 37000, France

COMPLETED

MeSH Terms

Conditions

Neoplasms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ulrike Schick, Doctor

  University Hospital, Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrike Schick, Doctor

CONTACT

0298223398; ulrike.schick@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 5, 2017
• Study Start: June 14, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: October 19, 2018

Record last verified: 2018-10

Locations

FR (4)