NCT04952480RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- First submitted
- 28 Jun 2021
- Start date
- 13 Jun 2022
- Primary completion date
- Mar 2028
- Lead sponsor
- AHS Cancer Control Alberta
- Diseases
- Lung cancer
- NCT number
- NCT04952480
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 31
- From 13 Jun 2022 to the primary completion date, Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Brain metastasis that has not been symptomatically stable on dexamethasone
- Previous CNS or thoracic radiotherapy
- Previous chemotherapy
- Ineligibility for platinum doublet chemotherapy
- Prior thoracic surgery
- 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
Other illness
- 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
- 4 or more sites of extrathoracic disease, even if 2 or more of these are present in the same organ system
- History of another primary malignancy other than cutaneous basal cell carcinoma unless disease-free for at least 5 years
- Lack of intrathoracic disease or intrathoracic disease spread not feasible to treat with adaptive radiotherapy
Lab values
- 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)
Other
- Life expectancy of less than 3 months
- Pregnant or breast-feeding
- Participant in development and conduct of the research study
Who the study is looking for
- 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.
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.