Limited Stage Small-Cell Lung CancerPhase 2/3SHARP SCLCNCT07920549
A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer
A Phase 2/3 study testing Radiation Therapy, Hypofractionated Radiation Therapy and Chemotherapy in people with Limited Stage Small-Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Limited Stage Small-Cell Lung Cancer
- What is being tested?
- Radiation Therapy, Hypofractionated Radiation Therapy and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2026to Sep 2036
- Phase
- Phase 2/3
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
London Health Sciences Centre, Verspeeten Family Cancer Centre
London, Ontario, N6A 5W9
Melody Qu, MD, 519-685-8650, Melody.Qu@lhsc.on.ca
Melody Qu, MD
About this study
Official title: 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).
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.
- Conditions
- Limited Stage Small-Cell Lung Cancer
- Being tested
- Radiation Therapy, Hypofractionated Radiation Therapy, Chemotherapy
- Keywords
- Radiotherapy, Small Cell Lung Cancer, LS-SCLC, Thoracic Radiotherapy, Hypofractionated Radiotherapy, Accelerated Radiotherapy, Progression-Free Survival, Radiation Dose Fractionation
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
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.
Hypofractionated Radiation TherapyRadiation
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.
ChemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Thoracic Radiotherapy | Active comparator | Not described Receives: Radiation: Radiation Therapy; Drug: Chemotherapy |
| Hypofractionated Accelerated Thoracic Radiotherapy | Experimental | Not described Receives: Radiation: Hypofractionated Radiation Therapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization to disease progression or death, assessed for up to 60 months.
Secondary outcomes (6)
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
Measured: From randomization to 60 months post-randomization
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.
Measured: From randomization to 60 months post-randomization
Overall Survival
Overall survival defined as time from randomization to death from any cause, or last follow-up, whichever occurs first
Measured: From randomization to 60 months post-randomization
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.
Measured: From randomization to 60 months post-enrollment
Freedom From Intracranial Progression
Freedom From Intracranial Progression defined as time from randomization to disease progression intracranially, or last follow-up, whichever occurs first.
Measured: From randomization to 60 months post-randomization
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.
Measured: From randomization to 60 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2036 (estimated)
- Study completionSep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited Stage Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melody Qu, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07920549
- Sponsor's protocol ID
- ReDA 17092
- Acronym
- SHARP SCLC
- Status last verified
- Nov 2026
- First submitted
- 13 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer (SHARP-SCLC)
- ClinicalTrials.gov ID
- NCT07920549
- Acronym / sponsor ID
- SHARP SCLC / ReDA 17092
- Conditions
- 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
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2036 (estimated)
- Study completion
- Sep 2036 (estimated)
- First posted
- 5 Nov 2026 (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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Thoracic Radiotherapy | Active comparator | Radiation: Radiation Therapy, Drug: Chemotherapy |
| Hypofractionated Accelerated Thoracic Radiotherapy | Experimental | Radiation: Hypofractionated Radiation Therapy, Drug: Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Prior thoracic radiation therapy (RT) which, in the opinion of the treating radiation oncologist, precludes the delivery of further thoracic 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
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 |
|---|---|---|
| Radiation TherapyStandard 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. | Radiation | Standard Thoracic Radiotherapy |
| Hypofractionated Radiation TherapyHypofractionated 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. | Radiation | Hypofractionated Accelerated Thoracic Radiotherapy |
| Chemotherapy4-6 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. | Drug | Hypofractionated Accelerated Thoracic Radiotherapy, Standard Thoracic Radiotherapy |
Primary outcome
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.
6 secondary outcomes
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
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
Overall Survival
Time frame: From randomization to 60 months post-randomization
Freedom From Intrathoracic Progression
Time frame: From randomization to 60 months post-enrollment
Freedom From Intracranial Progression
Time frame: From randomization to 60 months post-randomization
Cost-Effectiveness Analysis
Time frame: From randomization to 60 months post-randomization
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 5 Nov 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiation Therapy, Hypofractionated Radiation Therapy and Chemotherapy in people with Limited Stage Small-Cell Lung Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Melody Qu, MD (519-685-8650, Melody.Qu@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From randomization to disease progression or death, assessed for up to 60 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.