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Trial Title:
Shortened High-dose Palliative Radiotherapy for Lung Cancer
NCT ID:
NCT06483308
Condition:
Stage IV Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Radiotherapy
Lung Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Radiotherapy using 30Gy in 6 fractions (alternate days) over 12 days.
Arm group label:
Radiotherapy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospitals of North Midlands NHS Trust
Address:
City:
Stoke-on-Trent
Zip:
ST4 6QG
Country:
United Kingdom
Contact:
Last name:
Apurna Jegannathen
Facility:
Name:
University Hospitals Coventry and Warwcikshire
Address:
City:
Coventry
Zip:
CV2 2DX
Country:
United Kingdom
Contact:
Last name:
Manreet Thind
Phone:
02476966581
Email:
Manreet.Thind@uhcw.nhs.uk
Contact backup:
Last name:
Raj Shrimali
Facility:
Name:
University Hospitals Birmingham NHS Foundation Trust
Address:
City:
Birmingham
Zip:
B15 2
Country:
United Kingdom
Contact:
Last name:
Qamar Ghafoor
Facility:
Name:
The Shrewsbury and Telford Hospital NHS Trust
Address:
City:
Shrewsbury
Zip:
SY2 6LG
Country:
United Kingdom
Contact:
Last name:
Anirban Chatterjee
Start date:
December 1, 2024
Completion date:
March 31, 2027
Lead sponsor:
Agency:
University Hospitals Coventry and Warwickshire NHS Trust
Agency class:
Other
Source:
University Hospitals Coventry and Warwickshire NHS Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06483308