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

Carcinoma, Non-small-cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349102
• Other study ID #: GATING 2006
• Secondary ID: ET2005-052
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2006
• Last updated: January 31, 2017
• Start date: July 2006
• Est. completion date: January 2014

Study information

• Verified date: January 2017
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: January 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-small-cell Lung
• Pneumonia
• Radiation Pneumonitis

Intervention

Radiation:
• Free breathing
Free breathing during conformal radiation
• Breath holding
Breath holding during conformal radiation

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	Hôpital de la Pitié Salpêtrière	Paris
France	Hôpital Européen Georges Pompidou	Paris
France	Institut Curie	Paris
France	Centre Catalan d'Oncologie	Perpignan
France	Centre René Gauducheau	Saint Herblain

Sponsors (2)

Lead Sponsor	Collaborator
Centre Leon Berard	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View Citation

Claude L, Pérol 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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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