Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) … (NCT00349102) | Clinical Trial Compass
CompletedPhase 3
Prevention of Radiation Pneumonitis After Three-dimensional Conformal Radiation Therapy (3D-CRT) in Patients With Non-small-cell Lung Cancer
France242 participantsStarted 2006-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 lacta…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical, functional and radiological evaluations at 6-8 weeks and 10-12 weeks after the end of irradiation
Timeframe: 6-8 and 10-12 weeks after the end of irradiation