Stage IV Lung CancerSHiP-RtNCT06483308
Shortened High-dose Palliative Radiotherapy for Lung Cancer
A study testing Radiotherapy in people with Stage IV Lung Cancer, run by University Hospitals Coventry and Warwickshire NHS Trust at 4 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IV Lung Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 27 Nov 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham, West Midlands, B15 2
University Hospitals Coventry and Warwickshire
Coventry, Warwickshire, CV2 2DX
The Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, West Midlands, SY2 6LG
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
Official title: Shortened High-dose Palliative Radiotherapy for Lung Cancer (SHiP-Rt) Study
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.
- Conditions
- Stage IV Lung Cancer
- Being tested
- Radiotherapy
- Keywords
- Radiotherapy, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy using 30Gy in 6 fractions (alternate days) over 12 days.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Other | Not described Receives: Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of treatment without reporting grade 3-4 oesophagitis, within 4 weeks of completing RT, using CTCAE v4.03.
Measured: 4 weeks of completing RT
Secondary outcomes (6)
Toxicity if proposd hypofractionated high dose palliative RT using CTCAE v4.03
Measured: 12 months
Patient reported outcome measures (PROMS) using Quality-of Life Questionnaires (QLQ-C30 & QLQ-LC13)
Measured: 12 months
Disease response and progression
Measured: 12 months
Cost-savings calculations to compare the proposed treatment regime to the standard of care.
Measured: 12 months
Number of participants offered to participate in the study vs how many consent vs how many complete treatment
Measured: 12 months
Time to start systemic therapy from recruitment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start27 Nov 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stage IV Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483308
- Sponsor's protocol ID
- RS631323
- Acronym
- SHiP-Rt
- Status last verified
- Mar 2026
- First submitted
- 17 Jun 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41628919
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shortened High-dose Palliative Radiotherapy for Lung Cancer (SHiP-Rt) Study
- ClinicalTrials.gov ID
- NCT06483308
- Acronym / sponsor ID
- SHiP-Rt / RS631323
- Conditions
- Stage IV Lung Cancer
- Keywords
- Radiotherapy, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Other | Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiotherapyRadiotherapy using 30Gy in 6 fractions (alternate days) over 12 days. | Radiation | Radiotherapy |
Primary outcome
Successful completion of treatment without reporting grade 3-4 oesophagitis, within 4 weeks of completing RT, using CTCAE v4.03.
Time frame: 4 weeks of completing RT
6 secondary outcomes
Toxicity if proposd hypofractionated high dose palliative RT using CTCAE v4.03
Time frame: 12 months
Patient reported outcome measures (PROMS) using Quality-of Life Questionnaires (QLQ-C30 & QLQ-LC13)
Time frame: 12 months
Disease response and progression
Time frame: 12 months
Cost-savings calculations to compare the proposed treatment regime to the standard of care.
Time frame: 12 months
Number of participants offered to participate in the study vs how many consent vs how many complete treatment
Time frame: 12 months
Time to start systemic therapy from recruitment.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 41628919Shrimali 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy in people with Stage IV Lung Cancer, run by University Hospitals Coventry and Warwickshire NHS Trust at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of treatment without reporting grade 3-4 oesophagitis, within 4 weeks of completing RT, using CTCAE v4.03. (time frame: 4 weeks of completing RT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06483308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.