Palliative Thoracic ImmunoRT

NCT ID: NCT03705806

Last Updated: 2025-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-03

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer, Nonsmall Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Alex Sun, MD

Role: CONTACT

416-946-4501 ext. 2126

Luke Heaphy, BSc

Role: CONTACT

416-946-4501 ext. 4820

Facility Contacts

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Alex Sun, MD

Role: primary

416 946 4501 ext. 2126

Other Identifiers

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18-5327

Identifier Type: -

Identifier Source: org_study_id

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