Clinical trial · Interventional
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
NCT04952480CI-TRIAL-00090927DARTSrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Dose-escalated adaptive radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose-escalated adaptive chemoradiotherapy
- description
- 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.
- interventionNames
- Radiation: Dose-escalated adaptive radiotherapy
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Local failure rate
- timeFrame
- The local failure rate will be assessed at the time point of 24 months.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.