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

Phase 3

Completed

• Conditions: Carcinoma, Non-small-cell Lung
• Interventions: Radiation: Free breathing; Radiation: Breath holding

• Registration Number: NCT00349102
• Lead Sponsor: Centre Leon Berard

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-05
• Study First Submitted QC: 2006-07-05
• Study First Posted: 2006-07-06
• Primary Completion: 2012-01
• Study Completion: 2014-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Free breathing	Free breathing during conformal radiation
B	Breath holding	Breath holding during conformal radiation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	6-8 and 10-12 weeks after the end of irradiation

Trial Locations

Locations (7)

Centre Oscar Lambret; 🇫🇷 Lille, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Institut Curie; 🇫🇷 Paris, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hôpital de la Pitié Salpêtrière; 🇫🇷 Paris, France

Centre Catalan d'Oncologie; 🇫🇷 Perpignan, France

Centre René Gauducheau; 🇫🇷 Saint Herblain, France