Non-Small Cell Lung Cancer Clinical Trial
— PROACTIVEOfficial title:
A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
NCT number | NCT02752126 |
Other study ID # | PROACTIVE |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | September 1, 2020 |
Verified date | February 2021 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 90 |
Est. completion date | September 1, 2020 |
Est. primary completion date | August 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - American Joint Committee on Cancer (AJCC) 7th edition stage IV NSCLC or stage III not eligible for curative intent treatment - Intended to receive palliative radiotherapy to the thorax, to a dose of 30Gy in 10 fractions or 20Gy in 5 fractions. In either treatment arm at least 5cm of the esophagus should be in the intended treatment field. - Willingness and ability to provide informed consent - Eastern Cooperative Oncology Group (ECOG) performance status 0-3 - Age 18 years or older - Prior or planned systemic therapy (chemotherapy, immunotherapy, targeted agents) is permissible at the discretion of the treating medical oncologist, provided that no systemic treatment is given within 2 weeks prior to RT, concurrent with RT or within a 2-week period post RT. - Concurrent palliative RT to other metastatic sites is permissible - Life expectancy > 3 months Exclusion Criteria: - Prior thoracic RT - Serious medical comorbidities precluding RT - Pregnant or lactating women - Inability to attend the full course of RT or planned follow-up visits - Planned concurrent palliative RT to the stomach and/or liver - Congenital abnormalities of the esophagus or severe disorders of the esophagus (e.g. achalasia) |
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Atlantic Clinical Cancer Centre | Halifax | Nova Scotia |
Canada | Grand River Regional Cancer Centre/Grand River Hospital | Kitchener | Ontario |
Canada | London Regional Cancer Program | London | Ontario |
Canada | Trillium Health Partners - Credit Valley Hospital | Mississauga | ONT |
Canada | McGill University Health Centre | Montréal | Quebec |
Canada | Princess Margaret Hospital/ University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Survival | Survival | 6 months after completion of radiotherapy | |
Secondary | Toxicity Rate Differences | Differences in rates of grade 2 or higher toxicity between groups will be tested using the Fisher's Exact test. | 6 months after completion of radiotherapy | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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