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A phase II trial to determine the proportion of patients where the use of continuous positive airway pressure (CPAP) results in a superior radiation plan compared to standard planning procedures. The rationale for using CPAP with radiotherapy is based on its ability to increase the tidal volume, flatten the diaphragm thus reducing respiratory excursions.The resultant lung hyperinflation and reduced respiratory excursions can be harnessed for radiotherapy purposes by:
CPAP has been shown to be superior to free breathing radiotherapy (RT), however it remains unclear how much benefit it confers vs other motion management adjuncts such as deep inspiration breath hold (DIBH) or 4-DCT.
PRIMARY OBJECTIVE:
To determine the proportion of patients where the use of CPAP results in a superior radiation plan compared to standard planning procedures in each patient cohort
SECONDARY OBJECTIVES
To determine:
Breast-specific:
• Comparison of organ at risk (OAR) dose constraints between CPAP and deep DIBH)
SABR-specific:
Breast cancer patients will undergo normal free breathing and DIBH radiotherapy planning scans. An additional scan with CPAP will be done for the purpose of the study. Radiotherapy plans will be produced on both the DIBH and CPAP planning scans. The planning scan with the best dosimetry will be chosen for treatment. If CPAP has a better radiation plan, then the patient will have CPAP administered during their daily RT. The DIBH plans for each patient, will serve as controls SABR patients will undergo the standard 4-D or breath hold CT and then CPAP CT for the purpose of the study. Respiratory movements will be monitored by Varian RPM system. Radiotherapy plans will be produced from the standard CT and the CPAP CT for comparison.
Patients will be treated on the best plan The trial aim to recruit 70 patients with invasive carcinoma of the breast undergoing adjuvant radiotherapy that includes breast/chest-wall plus regional lymph nodes, and a convenient sample size of those undergoing SABR to lung or liver
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP Planned | Experimental | Radiotherapy planning with CPAP in addition to standard plans |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | CPAP in conjunction with radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiotherapy Plan Selection | To determine the proportion of patients where the use of continuous positive airway pressure (CPAP) results in a superior radiation plan compared to standard planning procedures in each patient cohort | 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Organ at Risk Dose Constraints | Comparison of organ at risk dose constraints between CPAP assisted and standard RT plans Breast-specific:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Jameson, FRACP | Contact | +64 7 839 8899 | Michael.jameson@waikatodhb.health.nz |
| Name | Affiliation | Role |
|---|---|---|
| Kenanao D Rantshilane, MBBS | Waikato Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Within subject comparison
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| 6-12 months |
| Compliance and Tolerability | Assessment of compliance with CPAP as well as documentation of patient experiences • Patient experience as documented on a questionnaire after planning CT and on the last week of treatment | 6-12 months |