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New treatment option for Small Cell Lung Cancer
Official title Dose-escalated Adaptive Radiotherapy of Thoracic Disease for Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT04952480
What this study is testing
What is Chemotherapy?
Chemotherapy is an investigational medicine, being studied as a potential treatment for small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Eligible for platinum doublet chemotherapy
- Eligible for thoracic radiotherapy, which can also include ipsilateral supraclavicular lymph node disease
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.