Modeling of the Response to Hypofractionated Stereotactic Pulmonary Irradiation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-14

Study Completion Date

2020-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Oncology

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No