Palliative Thoracic ImmunoRT

Lung Cancer Clinical Trial

Official title:

Evaluation of Toxicities With Thoracic Radiotherapy and Immune Checkpoint Inhibition in Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03705806
• Other study ID #: 18-5327
• Status: Recruiting
• Start date: October 3, 2018
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: University Health Network, Toronto
• Contact: Alex Sun, MD
• Phone: 416-946-4501
• Email: alex.sun[@]rmp.uhn.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Radiation related toxicities	rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading	up to 24 months
Primary	Patient Report Outcome	FACT-E	up to 12 months
Primary	Patient experience and anxiety related to Quality of Life	EQ-5D	up to 12 months
Secondary	Rate of Survival		1 year
Secondary	Rate of Survival		2 year
Secondary	Rate of Disease Recurrence	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.	3, 6, 12 months