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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

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