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A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus (PROACTIVE)

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ClinicalTrials.gov Identifier: NCT02752126
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Alexander Louie, Lawson Health Research Institute

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Radiation: Conventional radiotherapy Radiation: Esophageal-Sparing Intensity-Modulated Radiotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Randomized Phase III Study of Palliative Radiation of Advanced Central Tumors With Intentional Avoidance of the Esophagus
Study Start Date : June 2016
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Palliative Radiation
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.
Radiation: Conventional radiotherapy
Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions.

Experimental: Esophageal Sparing IMRT
Patients on the experimental arm will receive esophageal-sparing intensity-modulated radiotherapy, with the same dose(s) as in the standard arm.
Radiation: Esophageal-Sparing Intensity-Modulated Radiotherapy
Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Survival [ Time Frame: 6 months after completion of radiotherapy ]
    Survival

  2. Toxicity Rate Differences [ Time Frame: 6 months after completion of radiotherapy ]
    Differences in rates of grade 2 or higher toxicity between groups will be tested using the Fisher's Exact test.

  3. Progression-Free Survival [ Time Frame: 6 months after completion of radiotherapy ]
    Differences in local/regional progression-free survival will be tested using the stratified log-rank test

  4. Further Systemic Therapy [ Time Frame: 6 months after completion of radiotherapy ]
    Differences in number of cycles of further systemic therapy will be tested using the student's t-test

  5. Cost-Effectiveness/Utility Analysis [ Time Frame: 6 months after completion of radiotherapy ]
    European Quality of Life-5 Dimensions (EQ-5D) measurements will be converted into utilities to inform cost-effectiveness/utility analysis.

  6. Dosimetry Comparison - Gross Tumor Volume (GTV) [ Time Frame: 6 months after completion of radiotherapy ]
    Dosimetric comparison of GTV will be compared using the student's t-test.

  7. Dosimetry Comparison - Planning Target Volume (PTV) [ Time Frame: 6 months after completion of radiotherapy ]
    Dosimetric comparison of PTV will be compared using the student's t-test.

  8. Dosimetry Comparison - Pulmonary Metrics [ Time Frame: 6 months after completion of radiotherapy ]
    Dosimetric comparison of standard pulmonary metrics will be compared using the student's t-test.

  9. Dosimetry Comparison - Esophageal Metrics [ Time Frame: 6 months after completion of radiotherapy ]
    Dosimetric comparison of standard esophageal metrics will be compared using the student's t-test.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752126


Contacts
Contact: Alexander Louie, MD, PhD, MSc, FRCPC 519-685-8500 ext 53025 alexander.louie@lhsc.on.ca
Contact: Al Gratton 519-685-8618 albert.gratton@lhsc.on.ca

Locations
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Juliette Jordan    780-432-8992    Juliette.Jordan@albertahealthservices.ca   
Sub-Investigator: Alysa Fairchild, FRCP         
Sub-Investigator: Zsolt Gabos, FRCP         
Canada, Nova Scotia
Atlantic Clinical Cancer Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Jennifer MacVicar    902-473-7257    Jennifer.MacVicar@nshealth.ca   
Sub-Investigator: Liam Mulroy, FRCP         
Canada, Ontario
Grand River Regional Cancer Centre/Grand River Hospital Recruiting
Kitchener, Ontario, Canada, N2G 1G3
Contact: Darin Gopaul, FRCP    519-749-4380    darin.gopaul@grhosp.ca   
Contact: Elyse Wellhauser    : 519-749-4370 ext 2447    Elyse.Wellhauser@grhosp.on.ca   
Principal Investigator: Darindra Gopaul, FRCP         
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Anne O'Connell    519-685-8618    anne.oconnell@lhsc.on.ca   
Contact: Al Gratton    519-685-8618    albert.gratton@lhsc.on.ca   
Principal Investigator: Alexander Louie, MD, PhD, MSc, FRCPC         
Princess Margaret Hospital/ University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Andrea Bezjak, Msc, MDCM, FRCPC    (416) 946-2132    andrea.bezjak@rmp.uhn.on.ca   
Canada, ONT
Trillium Health Partners - Credit Valley Hospital Recruiting
Mississauga, ONT, Canada, L5M 2N1
Contact: Matthew D'Ascanio    (905) 813 1100 ext 5057    Matthew.d'ascanio@thp.ca   
Principal Investigator: Anthony Blade, MD, CM, PhD, FRCPC         
Canada, Quebec
McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H3H 2R9
Contact: Marianna Perna    514-934-1934 ext 43191    marianna.perna@muhc.mcgill.ca   
Principal Investigator: Sergio Faria, PhD         
Sponsors and Collaborators
Lawson Health Research Institute

Responsible Party: Alexander Louie, Radiation Oncologist, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02752126     History of Changes
Other Study ID Numbers: PROACTIVE
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alexander Louie, Lawson Health Research Institute:
Esophageal sparing
Conventional radiotherapy
Palliative radiation
Central lung tumors

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases