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A randomized phase II study of palliative radiation of advanced central lung tumors with intentional avoidance of the esophagus. Patients will be randomized between standard of care palliative thoracic radiation and esophageal-sparing intensity-modulated radiation therapy (ES-IMRT) in a 1:1 ratio. Radiotherapy will be administered as soon as possible following randomization and subjects will be followed for 1 year after completion of their radiation therapy. The primary endpoint is esophageal quality of life as measured by the Esophageal Cancer Subscore (ECS) of the Functional Assessment of Cancer Therapy-Esophagus (FACT-E).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Palliative Radiation | Active Comparator | Patients in the standard arm will receive a conventional radiotherapy dose will be either 30 gray (Gy) in 10 fraction or 20Gy in 5 fractions. Patients will be stratified by intended dose prior to randomization. Radiation for patients in the standard arm should adhere to the principles of palliative radiation, with goals of alleviating symptoms or preventing potential complications. |
|
| Esophageal Sparing IMRT | Experimental | Patients on the experimental arm will receive esophageal-sparing intensity-modulated radiotherapy, with the same dose(s) as in the standard arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional radiotherapy | Radiation | Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal Quality of Life | Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks. | 2 weeks after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | Survival | 6 months after completion of radiotherapy |
| Toxicity Rate Differences | Differences in rates of grade 2 or higher toxicity between groups will be tested using the Fisher's Exact test. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Edmonton | Alberta | T6G 1Z2 | Canada | ||
| Atlantic Clinical Cancer Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35201290 | Derived | Louie AV, Granton PV, Fairchild A, Bezjak A, Gopaul D, Mulroy L, Brade A, Warner A, Debenham B, Bowes D, Kuk J, Sun A, Hoover D, Rodrigues GB, Palma DA. Palliative Radiation for Advanced Central Lung Tumors With Intentional Avoidance of the Esophagus (PROACTIVE): A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):1-7. doi: 10.1001/jamaoncol.2021.7664. |
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| Esophageal-Sparing Intensity-Modulated Radiotherapy | Radiation | Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions. |
|
| 6 months after completion of radiotherapy |
| Progression-Free Survival | Differences in local/regional progression-free survival will be tested using the stratified log-rank test | 6 months after completion of radiotherapy |
| Further Systemic Therapy | Differences in number of cycles of further systemic therapy will be tested using the student's t-test | 6 months after completion of radiotherapy |
| Cost-Effectiveness/Utility Analysis | European Quality of Life-5 Dimensions (EQ-5D) measurements will be converted into utilities to inform cost-effectiveness/utility analysis. | 6 months after completion of radiotherapy |
| Dosimetry Comparison - Gross Tumor Volume (GTV) | Dosimetric comparison of GTV will be compared using the student's t-test. | 6 months after completion of radiotherapy |
| Dosimetry Comparison - Planning Target Volume (PTV) | Dosimetric comparison of PTV will be compared using the student's t-test. | 6 months after completion of radiotherapy |
| Dosimetry Comparison - Pulmonary Metrics | Dosimetric comparison of standard pulmonary metrics will be compared using the student's t-test. | 6 months after completion of radiotherapy |
| Dosimetry Comparison - Esophageal Metrics | Dosimetric comparison of standard esophageal metrics will be compared using the student's t-test. | 6 months after completion of radiotherapy |
| Halifax |
| Nova Scotia |
| B3H 1V7 |
| Canada |
| Grand River Regional Cancer Centre/Grand River Hospital | Kitchener | Ontario | N2G 1G3 | Canada |
| London Regional Cancer Program | London | Ontario | N6A 4L6 | Canada |
| Trillium Health Partners - Credit Valley Hospital | Mississauga | Ontario | L5M 2N1 | Canada |
| Princess Margaret Hospital/ University Health Network | Toronto | Ontario | M5G 2M9 | Canada |
| McGill University Health Centre | Montreal | Quebec | H3H 2R9 | Canada |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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