A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer (SHARP SCLC)

November 2, 2026 updated by: Melody Qu, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer (SHARP-SCLC)

This study aims to determine whether an abbreviated course of thoracic radiotherapy, delivered in five fractions over one week between chemotherapy cycles, improves progression-free survival compared with standard radiotherapy delivered concurrently with chemotherapy in patients with newly diagnosed limited-stage small cell lung cancer (LS-SCLC).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicentre, randomized clinical trial comparing two thoracic radiation therapy (RT) approaches for patients with newly diagnosed limited-stage small cell lung cancer (LS-SCLC).

Standard treatment for LS-SCLC involves chemotherapy combined with thoracic radiation therapy. Conventional radiation schedules require daily or twice-daily treatments over several weeks. This study will investigate whether a shorter, accelerated course of radiotherapy can improve progression-free survival while reducing treatment burden.

The primary outcome is progression-free survival, defined as the time from randomization to disease progression or death. Secondary outcomes include overall survival, treatment-related toxicity, patient-reported quality of life, and treatment burden.

The study also includes exploratory translational research involving blood samples and radiation dosimetric analyses to better understand the biological effects of different radiation schedules.

Participants will be followed for up to five years after randomization to assess short- and long-term outcomes.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre, Verspeeten Family Cancer Centre
        • Contact:
        • Principal Investigator:
          • Melody Qu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • New diagnosis of Limited-stage small cell lung cancer (LS-SCLC), eligible for curative intent concurrent chemoradiotherapy

    -- Planned for immunotherapy and prophylactic cranial irradiation is allowed and encouraged

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • Age 18 years or older

  • Life expectancy > 3 months

  • Willingness and ability to provide informed consent

Exclusion Criteria:

  • Prior thoracic radiation therapy (RT) which, in the opinion of the treating radiation oncologist, precludes the delivery of further thoracic RT

    • If there has been prior thoracic RT, a composite of all RT plans must be created, and the dose constraints herein must still be met
    • An allowance for 10% repair is permitted if at least 12 months have passed between the prior RT and the trial protocol specified RT

  • Serious medical comorbidities which, in the opinion of the treating radiation oncologist, preclude the delivery of RT

    -- This includes interstitial lung disease

  • Patients who have started systemic treatment for LS-SCLC but are unable to start radiation with cycle 3 or earlier (delaying scheduled chemotherapy without clinical indication) is not permitted

  • Pregnant or lactating women

  • Inability to attend the full course of RT or planed follow-up visits

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Thoracic Radiotherapy
Radiation: Radiation Therapy

Standard RT using VMAT or IMRT. Accepted standard-of-care fractionation schedules include:

  • 60-66 Gy in 30-33 daily fractions
  • 40-45 Gy in 15 daily fractions
  • 45 Gy in 30 twice-daily fractions Radiotherapy will begin as early as feasible, preferably during chemotherapy cycle 1 or 2, and no later than cycle 3.
Drug: Chemotherapy

4-6 cycles of intravenous (IV) cisplatin (75 mg/m2) or carboplatin (area under the curve of 5-6 mg/mL × min) given on day 1 or day 1-3 and etoposide (100 mg/m2) on days 1 to 3 every 3 weeks. Oral etoposide (200 mg/m²) is permitted in urgent situations and/or when IV etoposide is not feasible, at the treating clinician's discretion.
Experimental: Hypofractionated Accelerated Thoracic Radiotherapy
Drug: Chemotherapy

4-6 cycles of intravenous (IV) cisplatin (75 mg/m2) or carboplatin (area under the curve of 5-6 mg/mL × min) given on day 1 or day 1-3 and etoposide (100 mg/m2) on days 1 to 3 every 3 weeks. Oral etoposide (200 mg/m²) is permitted in urgent situations and/or when IV etoposide is not feasible, at the treating clinician's discretion.

Radiation: Hypofractionated Radiation Therapy

Hypofractionated radiotherapy using VMAT or IMRT, prescribed to a total dose of 35 Gy in 5 fractions, with a SIB to 40 Gy for GTV where feasible. Radiotherapy will begin as early as feasible, preferably during chemotherapy cycle 1 or 2, and no later than cycle 3. Radiation will be delivered between chemotherapy cycles, ideally on days 15-20 of the respective cycle to avoid the anticipated chemotherapy nadir, and will not be administered on chemotherapy treatment days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From randomization to disease progression or death, assessed for up to 60 months.

Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed using RECIST version 1.1 criteria. Participants without documented progression or death will be censored at the date of their last adequate disease assessment.
From randomization to disease progression or death, assessed for up to 60 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Quality of Life Measured by the Functional Assessment of Cancer Therapy: Lung (FACT-L), and EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaires
Time Frame: From randomization to 60 months post-randomization

Changes in quality of life as reported by the participant on the Functional Assessment of Cancer Therapy: Lung (FACT-L) and EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaires
From randomization to 60 months post-randomization
Acute and Chronic Physician-Reported Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time Frame: From randomization to 60 months post-randomization

Severity and grade of side effects of treatment as reported by the physician as grade 2 or greater, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
From randomization to 60 months post-randomization
Overall Survival
Time Frame: From randomization to 60 months post-randomization

Overall survival defined as time from randomization to death from any cause, or last follow-up, whichever occurs first
From randomization to 60 months post-randomization
Freedom From Intrathoracic Progression
Time Frame: From randomization to 60 months post-enrollment

Freedom From Intrathoracic Progression defined as time from randomization to disease progression with the thorax, or last follow-up, whichever occurs first.
From randomization to 60 months post-enrollment
Freedom From Intracranial Progression
Time Frame: From randomization to 60 months post-randomization

Freedom From Intracranial Progression defined as time from randomization to disease progression intracranially, or last follow-up, whichever occurs first.
From randomization to 60 months post-randomization
Cost-Effectiveness Analysis
Time Frame: From randomization to 60 months post-randomization

Patient-level data on survival, disease progression, treatment-related toxicity, healthcare utilization, and health-related quality of life (EQ-5D-5L) will inform a cost-effectiveness analysis, based on modelled costs and quality-adjusted life years.
From randomization to 60 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

September 1, 2036

Study Completion (Estimated)

September 1, 2036

Study Registration Dates

First Submitted

October 13, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 5, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReDA 17092

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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