Stage IV Lung Cancer
Conditions
Keywords
Radiotherapy, Lung Cancer
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.
Interventions
RADIATIONRadiotherapy
Radiotherapy using 30Gy in 6 fractions (alternate days) over 12 days.
Sponsors
University Hospitals Coventry and Warwickshire NHS Trust
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Toxicity if proposd hypofractionated high dose palliative RT using CTCAE v4.03 | 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed