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NCT Number: NCT06483308

Shortened High-dose Palliative Radiotherapy for Lung Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Stage IV Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, Staffordshire, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiotherapy

Radiation

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Toxicity if proposd hypofractionated high dose palliative RT using CTCAE v4.03

    Time frame: 12 months

  2. Patient reported outcome measures (PROMS) using Quality-of Life Questionnaires (QLQ-C30 & QLQ-LC13)

    Time frame: 12 months

  3. Disease response and progression

    Time frame: 12 months

  4. Cost-savings calculations to compare the proposed treatment regime to the standard of care.

    Time frame: 12 months

  5. Number of participants offered to participate in the study vs how many consent vs how many complete treatment

    Time frame: 12 months

  6. Time to start systemic therapy from recruitment.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study title

Shortened High-dose Palliative Radiotherapy for Lung Cancer (SHiP-Rt) Study

Acronym: SHiP-Rt

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jul 3, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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