Shortened High-dose Palliative Radiotherapy for Lung Cancer
Not Applicable
Recruiting
- Conditions
- Stage IV Lung Cancer
- Interventions
- Radiation: Radiotherapy
- Registration Number
- NCT06483308
- Brief Summary
The SHiP-Rt Study aims to investigate the safety and efficacy of reducing the number of RT fractions and RT duration, compared to the current standard of care (36Gy in 12 fractions over 16 days), by using shortened hypofractionated accelerated palliative radiotherapy (30Gy in 6 alternate-day fractions), aided by contemporary RT planning, verification, and delivery techniques.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 37
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Radiotherapy Radiotherapy -
- Primary Outcome Measures
Name Time Method Successful completion of treatment without reporting grade 3-4 oesophagitis, within 4 weeks of completing RT, using CTCAE v4.03. 4 weeks of completing RT
- Secondary Outcome Measures
Name Time Method Toxicity if proposd hypofractionated high dose palliative RT using CTCAE v4.03 12 months Number of participants offered to participate in the study vs how many consent vs how many complete treatment 12 months Time to start systemic therapy from recruitment. 12 months Patient reported outcome measures (PROMS) using Quality-of Life Questionnaires (QLQ-C30 & QLQ-LC13) 12 months Disease response and progression 12 months Cost-savings calculations to compare the proposed treatment regime to the standard of care. 12 months
Trial Locations
- Locations (4)
University Hospitals Coventry and Warwickshire
🇬🇧Coventry, Warwickshire, United Kingdom
University Hospitals of North Midlands NHS Trust
🇬🇧Stoke-on-Trent, Staffordshire, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, West Midlands, United Kingdom
The Shrewsbury and Telford Hospital NHS Trust
🇬🇧Shrewsbury, West Midlands, United Kingdom