Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Infections

Wounds and Injuries

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Pneumonia

Radiation Pneumonitis

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Communicable Diseases

Respiratory Tract Infections

Lung Diseases, Interstitial

Lung Injury

Radiation Injuries

Free breathing during conformal radiation

Breath holding during conformal radiation

Free breathing

Breath holding

Line CLAUDE, MD

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.

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.

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

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

Ministry of Health, France

Centre Leon Berard

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Tomotherapy: locally advanced lung cancer (Stage III) or left breast cancer. High Frequency Percussive Ventilation will be coupled to tomotherapy treatment. The alternative procedure is free breathing.

Linear accelerator: breast cancer or pulmonary cancers (Stage I/II) requiring a stereotaxic radiotherapy.

High Frequency Percussive Ventilation will be coupled to linear accelerator. The alternative procedure is Active Breathing Control (ABC).

High Frequency Percussive Ventilation

Active Breathing Control

Jean Bourhis, Prof

That study combines High Frequency Percussive Ventilation (HFPV) with radiotherapy treatment in patients with tumors that are moving with respiration like breast or lung cancers. The use of a High Frequency Percussive Ventilation system leads to the cessation of respiratory motions while administering radiotherapy (RT) to tumors which allows a reduction of the amount of irradiated normal tissues and which potentially decrease radiation-induced collateral damages.

Primary objective :

Demonstrate the clinical benefit of the HFPV coupled to thoracic radiotherapy in 2 distinct and frequent clinical situations :

1. Tomotherapy for lung and left breast tumors. The investigators assume that the volume of irradiated healthy tissue will be much less when using HFPV as compared to free breathing during tomotherapy sessions .
2. In comparison with Active Breathing Control (ABC system). The investigators assume that the HFPV will lead to breathing motions cessation the same way as the ABC system, but will abrogate pause times when administrating the radiotherapy. This will shorten the radiotherapy sessions for lung patients treated with stereotaxis and for breast cancer patients.

Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment

Radiotherapy treatment fractions (locally advanced lung: 33 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start.

Dose distribution will be determined for both situations and patients will be treated with the most favourable one.

Lung (5 fractions) or breast (25 fractions). Each patient will undergo a planning CT scan: one with HFPV and one without. The CT scan is done after the patient has been registered in the study and before treatment start.

The time of fractions administration will be compared to theoretical times of treatment when patient is free breathing (lung 45 min for 12Gy/ breast 10 min for 2Gy).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer	NCT00349102	Carcinoma, Non-...	Free breathing Breath holding	18 Years -	Centre Leon Berard
Study to Evaluate the Benefit of a High Frequency Ventilation System During Lung or Breast Cancer Radiotherapy Treatment	NCT02936947	Lung Cancer Breast Cancer	High Frequency ... Free breathing Active Breathin...	18 Years -	Centre Hospitalier Universitaire Vaudois

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