Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer

Launched by AHS CANCER CONTROL ALBERTA · Jun 28, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat small cell lung cancer (SCLC) using a method called adaptive radiotherapy. The main goal is to see how effective this type of radiation therapy is in controlling the cancer while also monitoring any side effects that patients might experience. The trial is currently recruiting participants, specifically adults aged 18 and older who have been newly diagnosed with untreated small cell lung cancer. To qualify, patients need to have specific test results showing that their cancer can be targeted with radiation and must be eligible for certain chemotherapy treatments.

If you decide to participate, you can expect to receive personalized radiation therapy that adapts based on how your cancer responds during treatment. Participants will need to follow specific study rules and attend follow-up appointments to check on their health and treatment progress. It's important to know that there are some criteria that could exclude you from joining, such as having other serious health issues or previous cancer treatments. If you're interested, discussing this with your healthcare team can help you understand if this trial might be a good option for you.

Gender

ALL

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