Back to resultsPhase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma (midP)
Primary Purpose
Non-small Cell Lung Cancer, Radiation Therapy, Locally Advanced Disease
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
mid-position radiation strategy
ITV
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
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
Sites / Locations
- Centre Léon Bérard
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
midP arm
ITV arm
Arm Description
Patients treated with midP radiotherapy strategy.
Patient treated with radiotherapy ITV strategy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Local tumor control rate
Overall survival
To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration
Full Information
NCT ID
NCT01635270
First Posted
June 29, 2012
Last Updated
February 4, 2021
Sponsor
Centre Leon Berard
Collaborators
CREATIS Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT01635270
Brief Title
Phase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma
Acronym
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).
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 12, 2012 (Actual)
Primary Completion Date
August 2020 (Actual)
Study Completion Date
August 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
CREATIS Laboratory
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Radiation Therapy, Locally Advanced Disease, Non-metastatic Disease, Non-resectable Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
midP arm
Arm Type
Experimental
Arm Description
Patients treated with midP radiotherapy strategy.
Arm Title
ITV arm
Arm Type
Active Comparator
Arm Description
Patient treated with radiotherapy ITV strategy
Intervention Type
Radiation
Intervention Name(s)
mid-position radiation strategy
Intervention Description
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
Intervention Name(s)
ITV
Intervention Description
The ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion.
Primary Outcome Measure Information:
Title
1 year Progression Free Survival rate
Description
Efficacy evaluation of the midP strategy in comparison with ITV strategy in patient with locally advanced, non-resected NSCL cancer treated with radiotherapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Local tumor control rate
Time Frame
1 year and 2 years after the end of irradiation
Title
Overall survival
Time Frame
1 year and 2 years post irradiation
Title
To determine acute and late pulmonary toxicity in the 2 arms, including respiratory functional exploration
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line CLAUDE, MD
Organizational Affiliation
Centre Léon Bérard, Lyon, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study Evaluating Mid-position Strategy in Radiotherapy Treatment for Patients With a Locally Advanced Non-small Cell Lung Carcinoma
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