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Palliative Thoracic ImmunoRT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03705806
Recruitment Status : Recruiting
First Posted : October 15, 2018
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.

Condition or disease Intervention/treatment
Lung Cancer, Nonsmall Cell Lung Cancer Radiation: Radiation combined with immunotherapy

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Radiation: Radiation combined with immunotherapy
    The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.


Primary Outcome Measures :
  1. Rate of Radiation related toxicities [ Time Frame: up to 24 months ]
    rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading

  2. Patient Report Outcome [ Time Frame: up to 12 months ]
    FACT-E

  3. Patient experience and anxiety related to Quality of Life [ Time Frame: up to 12 months ]
    EQ-5D


Secondary Outcome Measures :
  1. Rate of Survival [ Time Frame: 1 year ]
  2. Rate of Survival [ Time Frame: 2 year ]
  3. Rate of Disease Recurrence [ Time Frame: 3, 6, 12 months ]
    Patients will be followed for up to two years following the completion of their radiotherapy. They will undergo CT surveillance imaging as standard by routine immunotherapy protocol with a minimum of 3 scans at the 3, 6 and 12 month mark. Local and distant recurrence will be determined primarily by CTCAE with CT scans as per ir-RECIST v1.0 criteria.


Biospecimen Retention:   Samples Without DNA
Study procedures include blood draw at baseline, end of radiation treatment, and at 1 month follow up visit.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will include a population of patients with metastatic NSCLC on first or second line immunotherapy who have an indication for palliative thoracic radiation
Criteria

Inclusion Criteria:

  1. Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment.
  2. Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10).
  3. Receiving or planned to receive nivolumab or pembrolizumab
  4. Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks
  5. Age 18 or older
  6. ECOG Performance Status 0-2
  7. Life expectancy greater than 3 months
  8. Able and willing to provide informed consent
  9. Able to complete patient reported outcome questionnaires

Exclusion Criteria:

  1. Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia
  2. Previous history of thoracic radiotherapy with an overlapping field
  3. Previous history of checkpoint inhibitor related pneumonitis or esophagitis
  4. Pregnancy

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): NCT03705806


Contacts
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Contact: Alex Sun, MD 416-946-4501 ext 2126 alex.sun@rmp.uhn.ca
Contact: Luke Heaphy, BSc 416-946-4501 ext 4820 rmp.crp.regulatory.affairs@rmp.uhn.ca

Locations
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Canada, Ontario
University Health Network, Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Alex Sun, MD    416 946 4501 ext 2126    Alex.Sun@rmp.uhn.on.ca   
Principal Investigator: Alex Sun, MD         
Sponsors and Collaborators
University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03705806    
Other Study ID Numbers: 18-5327
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms