Shortened High-dose Palliative Radiotherapy for Lung Cancer | NCT06483308

Studies
Shortened High-dose Palliative Radiotherapy for Lung Cancer

NCT06483308

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Status

Active, not recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

37Estimated

Phase

Not Applicable

Conditions

Stage IV Lung Cancer

Interventions

Radiotherapy

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2024Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Jun 17, 2024

First Submission Date that Met QC Criteria

Jun 28, 2024

First Posted Date

Jul 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Radiotherapy	Other		Radiation: Radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Radiation	Radiotherapy using 30Gy in 6 fractions (alternate days) over 12 days.	Radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospitals of North Midlands NHS Trust		Stoke-on-Trent	Staffordshire	ST4 6QG	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41628919	Derived	Shrimali RK, Griffin E, Sturgess V, Jones M, Hiller L, Rogers J, Hamilton J, Peebles C, Jones B, Dunn J. Shortened High-dose Palliative Radiotherapy for Lung Cancer (SHiP-Rt): protocol for a single-arm, multicentre, phase II study. BMJ Open. 2026 Feb 2;16(2):e111350. doi: 10.1136/bmjopen-2025-111350.

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms