Palliative Thoracic ImmunoRT

Recruiting

• Conditions: Lung Cancer, Nonsmall Cell; Lung Cancer

• Registration Number: NCT03705806
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-15
• Study Start: 2018-10-03
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-25
• Last Update Posted: 2023-10-27
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient experience and anxiety related to Quality of Life	up to 12 months	EQ-5D
Rate of Radiation related toxicities	up to 24 months	rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading
Patient Report Outcome	up to 12 months	FACT-E

Secondary Outcome Measures

Name	Time	Method
Rate of Survival	2 year
Rate of Disease Recurrence	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.

Trial Locations

Locations (1)

University Health Network, Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada