Shortened high-dose radiotherapy for lung cancer treatment

Shortened High-dose Palliative Radiotherapy for Lung Cancer (SHiP-Rt) Study

This study tests a shorter and stronger radiation treatment for people with stage IV lung cancer to see if it works as well as the usual longer treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 37 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 4 sites (Stoke-on-Trent, Staffordshire and 3 other locations)
• Trial ID: NCT06483308 on ClinicalTrials.gov

What this trial studies

The SHiP-Rt Study investigates the safety and efficacy of a shortened hypofractionated accelerated palliative radiotherapy regimen for patients with stage IV lung cancer. This approach aims to reduce the number of treatment sessions and overall duration compared to the current standard of care. Patients will receive 30Gy in 6 alternate-day fractions, utilizing advanced radiotherapy planning and delivery techniques to enhance treatment outcomes. The study will compare this new regimen against the traditional 36Gy in 12 fractions over 16 days.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with locally advanced or metastatic non-small cell lung cancer who are treatment naïve or have had limited progression after first-line therapy.

Not a fit: Patients who have contraindications for thoracic radiotherapy or those requiring treatment after second-line systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more efficient and effective palliative treatment option for patients with advanced lung cancer.

How similar studies have performed: Other studies have explored hypofractionated radiotherapy approaches, showing promising results, but this specific regimen is novel in its application for stage IV lung cancer.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18
* Patient has locally advanced (stage IIIB or IIIC) or metastatic (stage IV) NSCLC
* Patient is treatment naïve or had limited progression after first-line systemic therapy (using chemotherapy, immunotherapy, or targeted therapy)
* Patient is suitable for high dose palliative RT (36Gy in 12# or 39Gy in 13#)
* Obtained written informed consent for the SHiP-Rt study.
* Patients receiving RT after first-line systemic therapy must have a wash-out period of at least 3 weeks (i.e., 3-4 weeks).
* Treatment naïve patients should be able to proceed to definitive systemic therapy without undue delay, i.e., within 3-4 weeks.

Exclusion Criteria:

* Contraindication for thoracic RT
* Requiring lung RT after second-line systemic therapy for NSCLC
* Has more than 1 cancer that is requiring active treatment
* On cytotoxic treatment for rheumatoid arthritis or connective tissue disorders
* Poor life expectancy, likely less than 6 months
* Patients with difficulty regarding compliance to the study treatment or follow-up
* Previous radiotherapy to the same area

Where this trial is running

Stoke-on-Trent, Staffordshire and 3 other locations

• University Hospitals of North Midlands NHS Trust — Stoke-on-Trent, Staffordshire, United Kingdom (Not_yet_recruiting)
• University Hospitals Coventry and Warwickshire — Coventry, Warwickshire, United Kingdom (Recruiting)
• University Hospitals Birmingham NHS Foundation Trust — Birmingham, West Midlands, United Kingdom (Not_yet_recruiting)
• The Shrewsbury and Telford Hospital NHS Trust — Shrewsbury, West Midlands, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Dr Raj Shrimali

Conditions Stage IV Lung Cancer; Radiotherapy; Lung Cancer