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

NCT01635270 | Completed Phase 2 DMC

• 3 other identifiers: midP2012-A00413-40ET12-033
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

midP arm

EXPERIMENTAL

Patients treated with midP radiotherapy strategy.

Radiation: mid-position radiation strategy

ITV arm

ACTIVE COMPARATOR

Patient treated with radiotherapy ITV strategy

Radiation: ITV

Interventions

mid-position radiation strategy 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

midP arm

ITV RADIATION

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

ITV arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient with a NSCLC, non-resected, non-metastatic including a parenchyma portion
• Age \>= 18 years
• PS \<=2
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead
• CREATIS Laboratory: collaborator

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Line CLAUDE, MD

  Centre Léon Bérard, Lyon, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 9, 2012
• Study Start: September 12, 2012
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: February 5, 2021

Record last verified: 2021-02

Locations

FR (1)