Adaptive radiotherapy for small cell lung cancer treatment
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
PHASE2 · AHS Cancer Control Alberta · NCT04952480
This study is testing a new type of personalized radiation therapy for people with small cell lung cancer to see if it can better control the cancer and reduce side effects compared to standard treatments.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AHS Cancer Control Alberta (other) |
| Drugs / interventions | chemotherapy, Radiation |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04952480 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of dose-escalated adaptive radiotherapy on controlling small cell lung cancer and managing side effects. It is an open-label, single-arm, phase II trial that compares this innovative radiotherapy approach to historical controls of standard treatment. Participants will receive tailored radiation therapy in three phases, with scheduled replans to adjust for tumor shrinkage, while also undergoing chemotherapy. The study aims to assess local failure rates, progression-free survival, overall survival, and radiation toxicity over a follow-up period of 24 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, untreated small cell lung cancer eligible for concurrent chemotherapy and radiotherapy.
Not a fit: Patients without intrathoracic disease or those with extensive extra-thoracic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve cancer control and reduce side effects for patients with small cell lung cancer.
How similar studies have performed: Other studies have shown promise with adaptive radiotherapy approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edmonton, Alberta
- Cross Cancer Institute — Edmonton, Alberta, Canada (RECRUITING)
Study contacts
- Principal investigator: Yee Don, MD — Cross Cancer Institute, Alberta Health Services
- Study coordinator: Yee Don, MD
- Email: don.yee@ahs.ca
- Phone: 780-432-8783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Small Cell Lung Cancer, Small cell lung cancer, Adaptive radiotherapy