NCT00349102

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2006

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 6, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

5.5 years

First QC Date

July 5, 2006

Last Update Submit

January 31, 2017

Conditions

Carcinoma, Non-small-cell Lung

Keywords

Non-small-cell lung cancerBreath-holdRadiation pneumonitisSerum cytokinesLENT-SOMA scaleNon-metastatic non-small-cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • 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 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

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

Study Arms (2)

A

ACTIVE COMPARATOR

Free breathing during conformal radiation

Radiation: Free breathing

B

EXPERIMENTAL

Breath holding during conformal radiation

Radiation: Breath holding

Interventions

Free breathingRADIATION

Free breathing during conformal radiation

Also known as: Conformal radiation, Lung cancer
A
Breath holdingRADIATION

Breath holding during conformal radiation

Also known as: Conformal radiation, Lung cancer
B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Léon Bérard

Lyon, 69008, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital de la Pitié Salpêtrière

Paris, 75013, France

Location

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Centre Catalan d'Oncologie

Perpignan, 66000, France

Location

Centre René Gauducheau

Saint-Herblain, 44805, France

Location

Related 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. doi: 10.1200/JCO.2005.01.7145.

    PMID: 16314635BACKGROUND

  • 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.

    PMID: 15110451BACKGROUND

  • 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

    RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungRadiation Pneumonitis

Interventions

Breath Holding

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesLung Diseases, InterstitialLung InjuryRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

RespirationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Line CLAUDE, MD

    Centre Leon Berard, Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2006

First Posted

July 6, 2006

Study Start

July 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2014

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

FR(7)