Non-Small Cell Lung CancerPROACTIVENCT02752126
A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
A study testing Conventional radiotherapy and Esophageal-Sparing Intensity-Modulated Radiotherapy in people with Non-Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 7 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Conventional radiotherapy and Esophageal-Sparing Intensity-Modulated Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 7 sitesCanada
- Study dates
- Jun 2016to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Atlantic Clinical Cancer Centre
Halifax, Nova Scotia, B3H 1V7
Grand River Regional Cancer Centre/Grand River Hospital
Kitchener, Ontario, N2G 1G3
London Regional Cancer Program
London, Ontario, N6A 4L6
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
McGill University Health Centre
Montreal, Quebec, H3H 2R9
Princess Margaret Hospital/ University Health Network
Toronto, Ontario, M5G 2M9
About this study
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).
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Conventional radiotherapy, Esophageal-Sparing Intensity-Modulated Radiotherapy
- Keywords
- Esophageal sparing, Conventional radiotherapy, Palliative radiation, Central lung tumors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional radiotherapyRadiation
Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions.
Esophageal-Sparing Intensity-Modulated RadiotherapyRadiation
Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Conventional radiotherapy |
| 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. Receives: Radiation: Esophageal-Sparing Intensity-Modulated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal Quality of Life
Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks.
Measured: 2 weeks after completion of radiotherapy
Secondary outcomes (9)
Survival
Survival
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startJun 2016
- Primary completion1 Aug 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Louie, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752126
- Sponsor's protocol ID
- PROACTIVE
- Acronym
- PROACTIVE
- Status last verified
- Feb 2021
- First submitted
- 22 Apr 2016
- Last updated
- 25 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 35201290
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
- ClinicalTrials.gov ID
- NCT02752126
- Acronym / sponsor ID
- PROACTIVE / PROACTIVE
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Esophageal sparing, Conventional radiotherapy, Palliative radiation, Central lung tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Palliative Radiation | Active comparator | Radiation: Conventional radiotherapyPatients 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 | Radiation: Esophageal-Sparing Intensity-Modulated RadiotherapyPatients on the experimental arm will receive esophageal-sparing intensity-modulated radiotherapy, with the same dose(s) as in the standard arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional radiotherapyPatients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions. | Radiation | Standard Palliative Radiation |
| Esophageal-Sparing Intensity-Modulated RadiotherapyPatients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions. | Radiation | Esophageal Sparing IMRT |
Primary outcome
Esophageal Quality of Life
Time frame: 2 weeks after completion of radiotherapy
Esophageal quality of life will be measured by the ECS of the FACT-E, measured at 2 weeks.
9 secondary outcomes
Survival
Time frame: 6 months after completion of radiotherapy
Toxicity Rate Differences
Time frame: 6 months after completion of radiotherapy
Progression-Free Survival
Time frame: 6 months after completion of radiotherapy
Further Systemic Therapy
Time frame: 6 months after completion of radiotherapy
Cost-Effectiveness/Utility Analysis
Time frame: 6 months after completion of radiotherapy
Dosimetry Comparison - Gross Tumor Volume (GTV)
Time frame: 6 months after completion of radiotherapy
Dosimetry Comparison - Planning Target Volume (PTV)
Time frame: 6 months after completion of radiotherapy
Dosimetry Comparison - Pulmonary Metrics
Time frame: 6 months after completion of radiotherapy
Dosimetry Comparison - Esophageal Metrics
Time frame: 6 months after completion of radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Derived from this study: PubMed 35201290Louie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional radiotherapy and Esophageal-Sparing Intensity-Modulated Radiotherapy in people with Non-Small Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal Quality of Life (time frame: 2 weeks after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.