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Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer

Primary Purpose

Carcinoma, Non-small-cell Lung

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Free breathing
Breath holding
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-small-cell Lung focused on measuring Non-small-cell lung cancer, Breath-hold, Radiation pneumonitis, Serum cytokines, LENT-SOMA scale, Non-metastatic non-small-cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Non-metastatic cytologically or histologically proven non-small-cell lung cancer (NSCLC) Operated NSCLC patients requiring post-surgical irradiation or non-operated NSCLC patients requiring curative irradiation Conformational thoracic radiotherapy with curative intent Age >= 18 Complete functional respiratory evaluation (FRE) performed less than 2 months before inclusion, demonstrating a maximum expiratory flow-volume/second > 1 l (in case surgery, the FRE must have been realized in the post-surgery period) Thoracic CT-scan performed less than 2 months before inclusion for non-operated patient PET-scan performed less than 2 months before inclusion for non-operated patient Performance status (PS) ECOG <= 1 Possible training on breath holding technique Female patients of childbearing potential: effective method of contraception necessary Mandatory affiliation with a social security system Written, signed, informed consent Exclusion Criteria: Small-cell lung cancer Metastatic disease Infiltrating pulmonary disease Previous thoracic irradiation Indication of irradiation with palliative intent Previous or concurrent primary malignancies at other sites (except basocellular skin cancer or cervical cancer in situ or complete remission for more than 5 years) Life expectancy < 6 months Patient understanding incompatible with the breath-hold technique (patients with major presbycusis are not eligible) Pregnant or lactating woman Patient included in another clinical trial Follow-up difficult Patient deprived of freedom

Sites / Locations

  • Centre Oscar Lambret
  • Centre Léon Bérard
  • Institut Curie
  • Hôpital de la Pitié Salpêtrière
  • Hôpital Européen Georges Pompidou
  • Centre Catalan d'Oncologie
  • Centre René Gauducheau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Free breathing during conformal radiation

Breath holding during conformal radiation

Outcomes

Primary Outcome Measures

Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation

Secondary Outcome Measures

RTOG and LENT-SOMA scores at 6-8 weeks and 10-12 weeks after the end of irradiation, response rates at 6-8 weeks, 1 year and 2 years after irradiation

Full Information

First Posted
July 5, 2006
Last Updated
January 31, 2017
Sponsor
Centre Leon Berard
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00349102
Brief Title
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer
Official Title
Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2006 (Actual)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the interest of breath holding for the prevention of radiation pneumonitis following conformal radiation therapy. Eligible patients will be randomly assigned in a 2-arm trial to free breathing or breath holding during conformal radiation. The primary objective of the study is to establish the efficacy of breath holding, compared to free breathing, in the prevention of early pulmonary toxicity following conformal radiation. Several departments of radiotherapy, many pneumology units and two basic and applied research laboratories take part in this multicentric study. The number of patients required to demonstrate a reduction in radiation pneumonitis from 45 % to 22.5 %, assuming an alpha risk of 5% in a two-sided test and 95% power, is 240 (120 per arm). With a planned accrual of 7 patients per month, it is estimated that the inclusion period should be approximately 3 years.
Detailed Description
The secondary objectives are: Validation of the Lent-Soma toxicity scale by comparison to the RTOG scale, Response rate at different times: week 6-8, 1 year and 2 years after the end of irradiation, Progression-free survival rate at 1 year and 2 years after the end of irradiation Confirmation of the predictive value of serum cytokine levels (IL-6 and IL-10) during irradiation for the occurrence of early radiation toxicity, and analysis of the correlation between these serum levels at inclusion and the expression polymorphism of candidate genes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Non-small-cell Lung
Keywords
Non-small-cell lung cancer, Breath-hold, Radiation pneumonitis, Serum cytokines, LENT-SOMA scale, Non-metastatic non-small-cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Free breathing during conformal radiation
Arm Title
B
Arm Type
Experimental
Arm Description
Breath holding during conformal radiation
Intervention Type
Radiation
Intervention Name(s)
Free breathing
Other Intervention Name(s)
Conformal radiation, Lung cancer
Intervention Description
Free breathing during conformal radiation
Intervention Type
Radiation
Intervention Name(s)
Breath holding
Other Intervention Name(s)
Conformal radiation, Lung cancer
Intervention Description
Breath holding during conformal radiation
Primary Outcome Measure Information:
Title
Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation
Time Frame
6-8 and 10-12 weeks after the end of irradiation
Secondary Outcome Measure Information:
Title
RTOG and LENT-SOMA scores at 6-8 weeks and 10-12 weeks after the end of irradiation, response rates at 6-8 weeks, 1 year and 2 years after irradiation
Time Frame
6-8 and 10-12 weeks after the end of irradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Non-metastatic cytologically or histologically proven non-small-cell lung cancer (NSCLC) Operated NSCLC patients requiring post-surgical irradiation or non-operated NSCLC patients requiring curative irradiation Conformational thoracic radiotherapy with curative intent Age >= 18 Complete functional respiratory evaluation (FRE) performed less than 2 months before inclusion, demonstrating a maximum expiratory flow-volume/second > 1 l (in case surgery, the FRE must have been realized in the post-surgery period) Thoracic CT-scan performed less than 2 months before inclusion for non-operated patient PET-scan performed less than 2 months before inclusion for non-operated patient Performance status (PS) ECOG <= 1 Possible training on breath holding technique Female patients of childbearing potential: effective method of contraception necessary Mandatory affiliation with a social security system Written, signed, informed consent Exclusion Criteria: Small-cell lung cancer Metastatic disease Infiltrating pulmonary disease Previous thoracic irradiation Indication of irradiation with palliative intent Previous or concurrent primary malignancies at other sites (except basocellular skin cancer or cervical cancer in situ or complete remission for more than 5 years) Life expectancy < 6 months Patient understanding incompatible with the breath-hold technique (patients with major presbycusis are not eligible) Pregnant or lactating woman Patient included in another clinical trial Follow-up difficult Patient deprived of freedom
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Line CLAUDE, MD
Organizational Affiliation
Centre Leon Berard, Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hôpital de la Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Catalan d'Oncologie
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Centre René Gauducheau
City
Saint Herblain
ZIP/Postal Code
44805
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16314635
Citation
Arpin D, Perol D, Blay JY, Falchero L, Claude L, Vuillermoz-Blas S, Martel-Lafay I, Ginestet C, Alberti L, Nosov D, Etienne-Mastroianni B, Cottin V, Perol M, Guerin JC, Cordier JF, Carrie C. Early variations of circulating interleukin-6 and interleukin-10 levels during thoracic radiotherapy are predictive for radiation pneumonitis. J Clin Oncol. 2005 Dec 1;23(34):8748-56. doi: 10.1200/JCO.2005.01.7145.
Results Reference
background
PubMed Identifier
15110451
Citation
Claude L, Perol D, Ginestet C, Falchero L, Arpin D, Vincent M, Martel I, Hominal S, Cordier JF, Carrie C. A prospective study on radiation pneumonitis following conformal radiation therapy in non-small-cell lung cancer: clinical and dosimetric factors analysis. Radiother Oncol. 2004 May;71(2):175-81. doi: 10.1016/j.radonc.2004.02.005.
Results Reference
background
Citation
L. Falchero, D. Perol, D. Arpin, M. Vincent, M. Perol, JF. Cordier, D. Boutry, I. Martel-Lafay, C. Carrie.- Conséquences fonctionnelles de la radiothérapie thoracique conformationnelle (r3d) et facteurs prédictifs de pneumopathie radique aiguë (PRA) chez des patients atteints de cancer bronchique non à petites cellules (CNPC). Rev. Mal. Resp., 2001 ; 18 (suppl) : 1S102
Results Reference
result

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Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer

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