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

Non-small Cell Lung Cancer Clinical Trial

— midP  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635270
• Other study ID #: midP
• Secondary ID: 2012-A00413-40ET
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2012
• Est. completion date: August 2020

Study information

• Verified date: February 2021
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Disease
• Lung Neoplasms
• Non-metastatic Disease
• Non-resectable Disease
• Non-small Cell Lung Cancer
• Radiation Therapy

Intervention

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

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	CREATIS Laboratory

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Local tumor control rate		1 year and 2 years after the end of irradiation
Secondary	Overall survival		1 year and 2 years post irradiation
Secondary	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