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

Phase 2

Completed

• Conditions: Locally Advanced Disease; Non-metastatic Disease; Non-small Cell Lung Cancer; Non-resectable Disease; Radiation Therapy
• Interventions: Radiation: mid-position radiation strategy; Radiation: ITV

• Registration Number: NCT01635270
• Lead Sponsor: Centre Leon Berard

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-29
• Study First Submitted QC: 2012-07-04
• Study First Posted: 2012-07-09
• Study Start: 2012-09-12
• Primary Completion: 2020-08
• Study Completion: 2020-08
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midP arm	mid-position radiation strategy	Patients treated with midP radiotherapy strategy.
ITV arm	ITV	Patient treated with radiotherapy ITV strategy

Primary Outcome Measures

Name	Time	Method
1 year Progression Free Survival rate	1 year	Efficacy evaluation of the midP strategy in comparison with ITV strategy in patient with locally advanced, non-resected NSCL cancer treated with radiotherapy

Secondary Outcome Measures

Name	Time	Method
Local tumor control rate	1 year and 2 years after the end of irradiation
Overall survival	1 year and 2 years post irradiation
To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration	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

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon, France