Active — Not RecruitingNot Applicable

Palliative Thoracic ImmunoRT

Canada12 participantsStarted 2018-10-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Rate of Radiation related toxicities

Timeframe: up to 24 months

Patient Report Outcome

Timeframe: up to 12 months

Patient experience and anxiety related to Quality of Life

Timeframe: up to 12 months

Trial details

NCT IDNCT03705806

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Lung Cancer, Nonsmall Cell trials