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

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).

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer; Radiation Therapy; Locally Advanced Disease; Non-metastatic Disease; Non-resectable Disease
• Intervention / Treatment: Radiation: mid-position radiation strategy; Radiation: ITV

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69373
    • Centre Léon Bérard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: midP arm; Patients treated with midP radiotherapy strategy.	Radiation: mid-position radiation strategy; The midP strategy defines the target as the time weighted average tumor position (mid-position) plus an additional margin, computed specifically for each patient, that takes into account the tumor motion in each direction. This strategy can help to safely reduce toxicity while preserving treatment efficacy
Active Comparator: ITV arm; Patient treated with radiotherapy ITV strategy	Radiation: ITV; The ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Collaborators: CREATIS Laboratory
• Investigators: Principal Investigator: Line CLAUDE, MD, Centre Léon Bérard, Lyon, France

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2012
• Primary Completion (Actual): August 1, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: June 29, 2012
• First Submitted That Met QC Criteria: July 4, 2012
• First Posted (Estimate): July 9, 2012

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: midP; 2012-A00413-40 (Other Identifier: ANSM number); ET12-033 (Other Identifier: Sponsor ID)