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

NCT ID: NCT01635270

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-12
• Study Completion Date: 2020-08-31

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.

Conditions

Non-small Cell Lung Cancer; Radiation Therapy; Locally Advanced Disease; Non-metastatic Disease; Non-resectable Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

midP arm

Patients treated with midP radiotherapy strategy.

Group Type: EXPERIMENTAL

mid-position radiation strategy

Intervention Type: RADIATION

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

ITV arm

Patient treated with radiotherapy ITV strategy

Group Type: ACTIVE_COMPARATOR

ITV

Intervention Type: RADIATION

The ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion.

Interventions

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

Intervention Type: RADIATION

ITV

The ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion.

Intervention Type: RADIATION

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CREATIS Laboratory

UNKNOWN

Sponsor Role: collaborator

Centre Leon Berard

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Line CLAUDE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Léon Bérard, Lyon, FRANCE

Locations

Centre Léon Bérard

Lyon, , France

Countries

France

Other Identifiers

2012-A00413-40

Identifier Type: OTHER

Identifier Source: secondary_id

ET12-033

Identifier Type: OTHER

Identifier Source: secondary_id

midP

Identifier Type: -

Identifier Source: org_study_id