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| Name | Class |
|---|---|
| Canadian Cancer Society (CCS) | OTHER |
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A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.
In patients with advanced NSCLC to compare the added benefit of High Dose Rate Intraluminal Brachytherapy (HDRIB) with External Beam Radiation (EBR). Benefit will be assessed by measuring the proportion of patients who achieve symptomatic improvement in lung cancer symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBR plus HDRIB | Experimental | External Beam Radiation (EBR) plus High Dose Rate Intraluminal Brachytherapy (HDRIB) |
|
| EBR | Active Comparator | External Beam Radiation (EBR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBR plus HDRIB | Radiation | EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| For each subject, a lung cancer-related symptomatic improvement at 6 weeks post randomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms | 6 weeks from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in each lung cancer symptom as measured by the Lung Cancer Symptom Scale (LCSS) as defined by a 10-point improvement for cough, shortness of breath, hemoptysis and pain on the LCSS at 6 weeks post randomization | 6 weeks post randomization | |
| Improvement in each lung cancer symptom and overall symptoms at any time after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ranjan Sur | Juravinski Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbotsford Centre - BC Cancer Agency | Abbotsford British Columbia | British Columbia | Canada | |||
| Juravinski Cancer Centre |
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| EBR | Radiation | EBR of 20 Gy in 5 daily fractions over one week |
|
| at 3, 6, 12, 18, 26, 34, 42 and 50 weeks post-randomization |
| A Quality of Life (QOL) improvement as measured be overall score of the LCSS, at each scheduled assessment point following randomization (Weeks 3, 6, 12, 26, 34, 42 and 50) | Weeks 3, 6, 12, 18, 26, 34, 42 and 50 |
| Symptomatic progression-free survival (SPFS), defined as the time from randomization until death, use of chemotherapy, or the first post-randomization score on LCSS #7 which is 10 points or greater than the baseline score, or scored at 100. | From date of randomization until the date of first documented use of chemotherapy, or progression whichever came first, assessed up to 48 months |
| Overall survival, calculated from the date of randomization to the date of death | From date of randomization until the date of death from any cause assessed up to 48 months |
| Hamilton |
| Ontario |
| L8V 5C2 |
| Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | Canada |
| Grand River Regional Cancer Centre | Kitchener | Ontario | N2K 2R2 | Canada |
| London Regional Cancer Centre | London | Ontario | Canada |
| UHN-Princess Margaret Cancer Centre | Toronto | Ontario | Canada |
| Windsor Regional Hospital Cancer Centre | Windsor | Ontario | N8W 2X3 | Canada |
| CHUQ - L'Hôtel-Dieu de Québec | Québec | Quebec | G1R 2J6 | Canada |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial 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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