Testing Dose-escalated adaptive radiotherapy with Chemotherapy for small cell lung cancer
Official title: Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer
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
- Phase 2
- 1 group
- One site, in Edmonton
- Recruiting
Interventions
- Radiation therapy
Dose-escalated adaptive radiotherapy
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.
- Medication
Chemotherapy
Concurrent standard of care platinum doublet based therapy
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta
Eligibility Criteria
See who this study is looking for28 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Minimum 18 years of age
- +Biopsy proven, newly diagnosed, untreated SCLC
- +Completed standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → 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 thoracic radiotherapy, which can also include ipsilateral supraclavicular lymph node disease
- +Capable of providing written, informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → prior to participation in the study. Patient's legally authorized representative (LAR) may sign on behalf of the patient.
- +Able and willing to comply with protocolProtocolThe detailed plan a study must follow.Read more → rules and follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → regimen
- +Pulmonary function tests showing FEV-1 \>1.0L and DLCO \> 50% predicted
- +Performance status of ECOG 0-2
- +Eligible for platinum doublet chemotherapy
- +Radiation-targetable intrathoracic disease
Exclusion
- −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-upFollow-upContinued check-ins after the treatment part is finished.Read more → imaging)
- −Brain metastasis that has not been symptomatically stable on dexamethasone
- −Thoracic disease is contiguous to extra-thoracic sites, beyond ipsilateral supraclavicular lymph nodes
- −Mixed histology disease
- −Active serious infection requiring therapy
- −4 or more sites of extrathoracic disease, even if 2 or more of these are present in the same organ system
- −Previous CNS or thoracic radiotherapy
- −Life expectancy of less than 3 months
- −History of another primary malignancy other than cutaneous basal cell carcinoma unless disease-free for at least 5 years
- −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 armArmOne of the groups in a study, each receiving something different.Read more →
- −Lack of intrathoracic disease or intrathoracic disease spread not feasible to treat with adaptive radiotherapy
- −Participant in development and conduct of the research study
- −Pregnant or breast-feeding
- −No intrathoracic disease seen to target with radiation
- −Previous chemotherapy
- −Ineligibility for platinum doublet chemotherapy
- −Prior thoracic surgery
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group, which receives one or more of: Dose-escalated adaptive radiotherapy and Chemotherapy.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 31 people.
The study is currently expected to finish around November 2025.
The main measurement is taken over: The local failure rate will be assessed at the time point of 24 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Local failure rate — measured over The local failure rate will be assessed at the time point of 24 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04952480 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About ChemotherapyDrug
Concurrent standard of care platinum doublet based therapy
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: The local failure rate will be assessed at the time point of 24 months..
The study as a whole is currently expected to finish around 2025-11-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 31 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Edmonton, Alberta, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.