Clinical trial NCT06483308: Shortened High-dose Palliative Radiotherapy for Lung Cancer
Official title: Shortened High-dose Palliative Radiotherapy for Lung Cancer (SHiP-Rt) Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stage IV Lung Cancer
Keywords: Radiotherapy
Lung Cancer
Lead sponsor: University Hospitals Coventry and Warwickshire NHS Trust
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Successful completion of treatment without reporting grade 3-4 oesophagitis, within 4 weeks of completing RT, using CTCAE v4.03.
timeFrame: 4 weeks of completing RT
Secondary outcomes:
measure: Toxicity if proposd hypofractionated high dose palliative RT using CTCAE v4.03
timeFrame: 12 months
measure: Patient reported outcome measures (PROMS) using Quality-of Life Questionnaires (QLQ-C30 & QLQ-LC13)
timeFrame: 12 months
measure: Disease response and progression
timeFrame: 12 months
measure: Cost-savings calculations to compare the proposed treatment regime to the standard of care.
timeFrame: 12 months
measure: Number of participants offered to participate in the study vs how many consent vs how many complete treatment
timeFrame: 12 months
measure: Time to start systemic therapy from recruitment.
timeFrame: 12 months
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
state: Staffordshire
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire
state: Warwickshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
state: West Midlands
city: Shrewsbury
country: United Kingdom
facility: The Shrewsbury and Telford Hospital NHS Trust
state: West Midlands
Study officials:
References: