Small Cell Lung CancerPhase 2DARTSNCT04952480
Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer
A Phase 2 study testing Dose-escalated adaptive radiotherapy and Chemotherapy in people with Small Cell Lung Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to find out what effects of using adaptive radiotherapy to deliver chest radiation has on the ability to control lung cancer and side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- Dose-escalated adaptive radiotherapy and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jun 2022to Mar 2028
- Phase
- Phase 2
- 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
- Minimum 18 years of age
- Biopsy proven, newly diagnosed, untreated SCLC
- Completed standard of care staging investigations including: CT chest/abdomen/pelvis, bone scan and/or or PET-CT scan, CT head or MRI brain, or chest X-ray
- Eligible for platinum doublet chemotherapy
- Eligible for thoracic radiotherapy, which can also include ipsilateral supraclavicular lymph node disease
- Capable of providing written, informed consent prior to participation in the study. Patient's legally authorized representative (LAR) may sign on behalf of the patient.
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- Able and willing to comply with protocol rules and follow-up regimen
- Performance status of ECOG 0-2
- Pulmonary function tests showing FEV-1 >1.0L and DLCO > 50% predicted
- Radiation-targetable intrathoracic disease
Who cannot join
- No intrathoracic disease seen to target with radiation
- Thoracic disease is contiguous to extra-thoracic sites, beyond ipsilateral supraclavicular lymph nodes
- Mixed histology disease
- Active serious infection requiring therapy
- Brain metastasis that has not been symptomatically stable on dexamethasone
- 4 or more sites of extrathoracic disease, even if 2 or more of these are present in the same organ system
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- Previous CNS or thoracic radiotherapy
- Previous chemotherapy
- Ineligibility for platinum doublet chemotherapy
- Life expectancy of less than 3 months
- Prior thoracic surgery
- History of another primary malignancy other than cutaneous basal cell carcinoma unless disease-free for at least 5 years
- Pregnant or breast-feeding
- In LS-SCLC, patients that are not eligible for concurrent chemoradiotherapy
- In ES-SCLC, patients that are not eligible for concurrent chemoradiotherapy under the experimental arm
- CT contrast allergy or kidney disease with irreversibly low creatinine clearance inadequate for IV contrast administration (for the purposes of high quality contrast enhanced CT chest and abdomen for follow-up imaging)
- Lack of intrathoracic disease or intrathoracic disease spread not feasible to treat with adaptive radiotherapy
- Participant in development and conduct of the research study
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, 1 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
About this study
Official title: Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer (DARTS): A Prospective Phase II Trial Evaluating Local Control of Adaptive Dose-escalated Radiotherapy
The purpose of this study is to find out what effects of using adaptive radiotherapy to deliver chest radiation has on the ability to control lung cancer and side effects.
Read the detailed description
This will be an open-label, single-arm, phase II study comparing dose escalated adaptive thoracic radiotherapy to historical control of standard of care single planned radiotherapy field for entire treatment course in patients with newly diagnosed limited stage small cell lung cancer eligible for concurrent chemoradiation with platinum doublet based chemotherapy, or extensive stage small cell lung cancer patients with radiation-targetable intra-thoracic disease and none or limited extra-thoracic disease that are eligible for up-front platinum doublet chemotherapy and are fit to receive concurrent radiotherapy.
The adaptive dose-escalated radiotherapy treatment plan will be delivered in three sequential phases with two scheduled replans during the treatment along with scaled dose limits for organs-at-risk. Up to 70 Gy in 35 fractions can be delivered to the disease without overdosing organs-at-risk, and treatment will last 5 - 7 weeks. Scheduled CT simulations for the replans will be at fraction 5 and fraction 10 to account for the expected rapidly shrinking tumour volumes. Participants will be followed for 24 months to investigate local failure rate, medium progression-free survival, overall survival, acute radiation toxicity, and late radiation toxicity. Follow-up after the study will be as per standard-of-care for secondary endpoints.
- Conditions
- Small Cell Lung Cancer
- Being tested
- Dose-escalated adaptive radiotherapy, Chemotherapy
- Keywords
- Small cell lung cancer, (Dose-escalated) Adaptive radiotherapy
- 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.
Dose-escalated adaptive radiotherapyRadiation
Adaptive planning of Radiation Therapy with two re-plans of the treatment field through course of therapy with the shrinking treatment fields according to tumor response to escalate dose, as allowed by dose to organs-at-risk.
ChemotherapyDrug
Concurrent standard of care platinum doublet based therapy
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalated adaptive chemoradiotherapy | Experimental | Concurrent with standard of care platinum doublet based chemotherapy (cisplatin + etoposide), radiation treatment plan will be delivered in three sequential phases with two scheduled replans during the treatment along with scaled dose limits for organs-at-risk: Phase 1 dose prescription = 14 Gy in 7 fractions; Phase 2 dose prescription = 10 Gy in 5 fractions starting the day after the final (7th) fraction is delivered; Phase 3 dose prescription = either a) 70 Gy in 35 fractions, or if this cannot be safely reached without exceeding the dose limit of an organ-at-risk, b) the maximum safe prescribe-able dose tolerance specified in the protocol. Either 3D conformal radiotherapy or IMRT planning and delivery techniques will be employed, including contouring relevant thoracic organs-at-risk. All CT simulation scans will be without contrast. Receives: Radiation: Dose-escalated adaptive radiotherapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local failure rate
The time from diagnostic biopsy to documented progression of intrathoracic disease as assessed by CT or X-ray imaging.
Measured: The local failure rate will be assessed at the time point of 24 months.
Secondary outcomes (4)
Progression-free survival
Time from diagnostic biopsy to first documented clinical or radiographic evidence of local progression or new metastatic disease.
Measured: Median time to PFS in study population. Expected to be within 24 months.
Overall survival
Time from diagnostic biopsy to death of the patient.
Measured: Median time to OS in study population. Expected to be within 24 months.
Acute radiation toxicity
Toxicity during and in the 3 months after radiotherapy as defined by CTCAE v.5 for esophagus, skin, lung, heart, and subcutaneous tissue.
Measured: Expected to be within 3 months.
Late radiation toxicity
Toxicity seen 3 months after radiotherapy as defined by CTCAE v.5 for esophagus, skin, lung, heart, and subcutaneous tissue.
Measured: Late toxicity will be assessed up to 24 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start13 Jun 2022
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yee Don, MD, Principal investigator, Cross Cancer Institute, Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952480
- Sponsor's protocol ID
- IIT-0015
- Acronym
- DARTS
- Status last verified
- Oct 2026
- First submitted
- 28 Jun 2021
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer (DARTS): A Prospective Phase II Trial Evaluating Local Control of Adaptive Dose-escalated Radiotherapy
- ClinicalTrials.gov ID
- NCT04952480
- Acronym / sponsor ID
- DARTS / IIT-0015
- Conditions
- Small Cell Lung Cancer
- Keywords
- Small cell lung cancer, (Dose-escalated) Adaptive radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 7 Jul 2021 (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 purpose of this study is to find out what effects of using adaptive radiotherapy to deliver chest radiation has on the ability to control lung cancer and side effects.
Detailed description
This will be an open-label, single-arm, phase II study comparing dose escalated adaptive thoracic radiotherapy to historical control of standard of care single planned radiotherapy field for entire treatment course in patients with newly diagnosed limited stage small cell lung cancer eligible for concurrent chemoradiation with platinum doublet based chemotherapy, or extensive stage small cell lung cancer patients with radiation-targetable intra-thoracic disease and none or limited extra-thoracic disease that are eligible for up-front platinum doublet chemotherapy and are fit to receive concurrent radiotherapy.
The adaptive dose-escalated radiotherapy treatment plan will be delivered in three sequential phases with two scheduled replans during the treatment along with scaled dose limits for organs-at-risk. Up to 70 Gy in 35 fractions can be delivered to the disease without overdosing organs-at-risk, and treatment will last 5 - 7 weeks. Scheduled CT simulations for the replans will be at fraction 5 and fraction 10 to account for the expected rapidly shrinking tumour volumes. Participants will be followed for 24 months to investigate local failure rate, medium progression-free survival, overall survival, acute radiation toxicity, and late radiation toxicity. Follow-up after the study will be as per standard-of-care for secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose-escalated adaptive chemoradiotherapy | Experimental | Radiation: Dose-escalated adaptive radiotherapy, Drug: ChemotherapyConcurrent with standard of care platinum doublet based chemotherapy (cisplatin + etoposide), radiation treatment plan will be delivered in three sequential phases with two scheduled replans during the treatment along with scaled dose limits for organs-at-risk: Phase 1 dose prescription = 14 Gy in 7 fractions; Phase 2 dose prescription = 10 Gy in 5 fractions starting the day after the final (7th) fraction is delivered; Phase 3 dose prescription = either a) 70 Gy in 35 fractions, or if this cannot be safely reached without exceeding the dose limit of an organ-at-risk, b) the maximum safe prescribe-able dose tolerance specified in the protocol. Either 3D conformal radiotherapy or IMRT planning and delivery techniques will be employed, including contouring relevant thoracic organs-at-risk. All CT simulation scans will be without contrast. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Minimum 18 years of age
- Biopsy proven, newly diagnosed, untreated SCLC
- Completed standard of care staging investigations including: CT chest/abdomen/pelvis, bone scan and/or or PET-CT scan, CT head or MRI brain, or chest X-ray
- Eligible for platinum doublet chemotherapy
- Eligible for thoracic radiotherapy, which can also include ipsilateral supraclavicular lymph node disease
Key exclusion criteria (18 listed)
- No intrathoracic disease seen to target with radiation
- Thoracic disease is contiguous to extra-thoracic sites, beyond ipsilateral supraclavicular lymph nodes
- Mixed histology disease
- Active serious infection requiring therapy
- Brain metastasis that has not been symptomatically stable on dexamethasone
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 |
|---|---|---|
| Dose-escalated adaptive radiotherapyAdaptive planning of Radiation Therapy with two re-plans of the treatment field through course of therapy with the shrinking treatment fields according to tumor response to escalate dose, as allowed by dose to organs-at-risk. | Radiation | Dose-escalated adaptive chemoradiotherapy |
| ChemotherapyConcurrent standard of care platinum doublet based therapy | Drug | Dose-escalated adaptive chemoradiotherapy |
Primary outcome
Local failure rate
Time frame: The local failure rate will be assessed at the time point of 24 months.
The time from diagnostic biopsy to documented progression of intrathoracic disease as assessed by CT or X-ray imaging.
4 secondary outcomes
Progression-free survival
Time frame: Median time to PFS in study population. Expected to be within 24 months.
Overall survival
Time frame: Median time to OS in study population. Expected to be within 24 months.
Acute radiation toxicity
Time frame: Expected to be within 3 months.
Late radiation toxicity
Time frame: Late toxicity will be assessed up to 24 months post-treatment.
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 3 Nov 2026.
- Individual participant dataSharing planned: No
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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.
Yee Don, MD principal investigator
Cross Cancer Institute, Alberta Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose-escalated adaptive radiotherapy and Chemotherapy in people with Small Cell Lung Cancer, run by AHS Cancer Control Alberta 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 10 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 3 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 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.
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 Yee Don, MD (780-432-8783, don.yee@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local failure rate (time frame: The local failure rate will be assessed at the time point of 24 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 3 Nov 2026.