Clinical trial NCT01635270: Phase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma
Official title: Randomized Phase 2 Study Evaluating the Interest of Mid-position Strategy Versus ITV (Internal Target Volume) Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-resected Non-small Cell Lung Carcinoma (NSCLC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Radiation Therapy
Locally Advanced Disease
Non-metastatic Disease
Non-resectable Disease
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: CREATIS Laboratory
First posted: 2012-07-09
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 1 year Progression Free Survival rate
timeFrame: 1 year
Secondary outcomes:
measure: Local tumor control rate
timeFrame: 1 year and 2 years after the end of irradiation
measure: Overall survival
timeFrame: 1 year and 2 years post irradiation
measure: To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration
timeFrame: Week1; Week 2; Week3; Week4; Week5; Week6; Week7 during the radiation, then 4 weeks, 3 months; 6 months ,one year and 2 years after the irradiation beginning
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Léon Bérard, Lyon, FRANCE
name: Line CLAUDE, MD
role: PRINCIPAL_INVESTIGATOR
References: