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NCT Number: NCT00349102

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

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Diseases, Interstitial Lung Injury Lung Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Radiation Pneumonitis Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Oscar Lambret, Lille, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Free breathing

Radiation

Free breathing during conformal radiation

Other names: Conformal radiation, Lung cancer

Breath holding

Radiation

Breath holding during conformal radiation

Other names: Conformal radiation, Lung cancer

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2012
Study completion
2014
First posted
Jul 6, 2006
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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