NCT06483308

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
14mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Nov 2024Jun 2027

First Submitted

Initial submission to the registry

June 17, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

November 27, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

June 17, 2024

Last Update Submit

April 9, 2026

Conditions

Stage IV Lung Cancer

Keywords

RadiotherapyLung Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Radiotherapy

OTHER
Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION

Radiotherapy using 30Gy in 6 fractions (alternate days) over 12 days.

Radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

University Hospitals Coventry and Warwickshire

Coventry, Warwickshire, CV2 2DX, United Kingdom

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, West Midlands, B15 2, United Kingdom

Location

The Shrewsbury and Telford Hospital NHS Trust

Shrewsbury, West Midlands, SY2 6LG, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 41628919DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2024

First Posted

July 3, 2024

Study Start

November 27, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 13, 2026

Record last verified: 2026-03

Locations

GB(4)