NCT04952480 Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer
| NCT ID | NCT04952480 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AHS Cancer Control Alberta |
| Condition | Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2022-06-13 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 31 participants in total. It began in 2022-06-13 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Yee Don, MD
PRINCIPAL INVESTIGATOR
Cross Cancer Institute, Alberta Health Services
Frequently Asked Questions
Who can join the NCT04952480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04952480 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04952480 currently recruiting?
Yes, NCT04952480 is actively recruiting participants. Contact the research team at don.yee@ahs.ca for enrollment information.
Where is the NCT04952480 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT04952480 clinical trial?
NCT04952480 is sponsored by AHS Cancer Control Alberta. The principal investigator is Yee Don, MD at Cross Cancer Institute, Alberta Health Services. The trial plans to enroll 31 participants.
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