Phase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma (midP)

Léon Bérard Center

Status and phase

Completed

Phase 2

Conditions

Radiation Therapy

Non-resectable Disease

Non-metastatic Disease

Non-small Cell Lung Cancer

Locally Advanced Disease

Treatments

Radiation: mid-position radiation strategy

Radiation: ITV

Study type

Interventional

Funder types

Other

Identifiers

NCT01635270

2012-A00413-40 (Other Identifier)

midP

ET12-033 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to establish on the market and to clinically evaluate a new strategy of treatment for patients with locally advanced non-small cell lung cancer using deformable repositioning of 4D imaging.

Enrollment

54 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

patient with a NSCLC, non-resected, non-metastatic including a parenchyma portion
Age >= 18 years
PS <=2
CT-scan within 3 months at inclusion
PET-scan within 3 months at inclusion
Respiratory functional exploration within 3 months at inclusion
estimated V20 (by radiotherapist)< 35% on conventional pre-radiotherapy imaging
Tumor T0 to T4, M0; N1, N2 ou N3 by isolateral supra-clavicular involvement
Measurable disease according to RECIST criteria 1.1
Curative intent Chest conventional radiation therapy
Radiation indication validated by a multidisciplinary meeting
Adequate contraceptive method for the whole study duration and for up to 28 days after the end of radiation
Mandatory affiliation with a health insurance company
Patients must provide dated & written consent

Exclusion criteria

Prior surgery for NSCLC
NSCLC nearby pulmonary apex or strictly intra-thoracic with no intra-parenchyma portion
Metastatic disease or N3 contralateral lymph node
History of chest irradiation
History of known increased intrinsic radiosensibility
Hypersensibility to active substance or excipient of fluoro-deoxyglucose-18F
Life expectancy < 6 months
Patient with a concurrent malignancy or with a history of malignancy (excepted adequately treated basal cell skin carcinoma or cervical squamous cell carcinoma or other malignancies free of the disease for at least 5 years)
Pregnant or breastfeeding women
Psychological, sociological or geographical conditions that would limit compliance with study requirements
Patient deprived of freedom
Patient has concomitant participation to an other investigational study