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Not yet recruitingNCT07920549SHARP SCLCUpdated Nov 5, 2026

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

A Phase 2/3 interventional study of Radiation Therapy and Hypofractionated Radiation Therapy in Limited Stage Small-Cell Lung Cancer, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 2/3, Interventional, and Treatment

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Limited Stage Small-Cell Lung Cancer

Keywords

  • Radiotherapy
  • Small Cell Lung Cancer
  • LS-SCLC
  • Thoracic Radiotherapy
  • Hypofractionated Radiotherapy
  • Accelerated Radiotherapy
  • Progression-Free Survival
  • Radiation Dose Fractionation
03

In context

Small Cell Lung Carcinoma

1,301 studies on the registry are indexed under Small Cell Lung Carcinoma; 367 are open to participants now.

This study's planned enrollment of 150 is above the median of 56 across 1,077 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 331 studies on the registry; 137 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

  • (ECOG) performance status 0-2
  • Age 18 years or older
  • > 3 months
  • Willingness and ability to provide

Exclusion criteria

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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Standard Thoracic Radiotherapy

    Radiation: Radiation Therapy · Drug: Chemotherapy

  • Experimental
    Hypofractionated Accelerated Thoracic Radiotherapy

    Radiation: Hypofractionated Radiation Therapy · Drug: Chemotherapy

Interventions

  • RadiationRadiation 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.

  • RadiationHypofractionated 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.

  • DrugChemotherapy

    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.

06

What researchers measure

Primary outcomes

  1. Progression-free survival

    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.

    Time frame: From randomization to disease progression or death, assessed for up to 60 months.

Secondary outcomes

  1. 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

    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

    Time frame: From randomization to 60 months post-randomization

  2. Acute and Chronic Physician-Reported Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    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.

    Time frame: From randomization to 60 months post-randomization

  3. Overall Survival

    Overall survival defined as time from randomization to death from any cause, or last follow-up, whichever occurs first

    Time frame: From randomization to 60 months post-randomization

  4. Freedom From Intrathoracic Progression

    Freedom From Intrathoracic Progression defined as time from randomization to disease progression with the thorax, or last follow-up, whichever occurs first.

    Time frame: From randomization to 60 months post-enrollment

  5. Freedom From Intracranial Progression

    Freedom From Intracranial Progression defined as time from randomization to disease progression intracranially, or last follow-up, whichever occurs first.

    Time frame: From randomization to 60 months post-randomization

  6. Cost-Effectiveness Analysis

    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.

    Time frame: From randomization to 60 months post-randomization

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Sep 2036, 118 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2026
First posted
Nov 5, 2026
StartEst.
Nov 2026
Primary completionEst.
Sep 2036
CompletionEst.
Sep 2036
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07920549
Responsible party
Melody Qu (Principal Investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Principal investigator
First posted
Nov 5, 2026
Start date
Nov 2026 (estimated)
Primary completion
Sep 2036 (estimated)
Completion
Sep 2036 (estimated)
Last update
Nov 5, 2026

Study contacts

Melody Qu, MD
Contact
Melody.Qu@lhsc.on.ca
519-685-8650

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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