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

January 31, 2017 updated by: Centre Leon Berard

Evaluation of the Interest of Breath Holding for the Prevention of Radiation Pneumonitis Following Conformal Radiation Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 69008
        • Centre Leon Berard
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75013
        • Hopital de La Pitie Salpetriere
      • Perpignan, France, 66000
        • Centre Catalan d'Oncologie
      • Saint Herblain, France, 44805
        • Centre Rene Gauducheau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Free breathing during conformal radiation
Radiation: Free breathing
Free breathing during conformal radiation
Other Names:
  • Conformal radiation
  • Lung cancer
Experimental: B
Breath holding during conformal radiation
Radiation: Breath holding
Breath holding during conformal radiation
Other Names:
  • Conformal radiation
  • Lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6-8 and 10-12 weeks after the end of irradiation

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6-8 and 10-12 weeks after the end of irradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Line CLAUDE, MD, Centre Léon Bérard, Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2006

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 5, 2006

First Submitted That Met QC Criteria

July 5, 2006

First Posted (Estimate)

July 6, 2006

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GATING 2006
  • ET2005-052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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