Testing whether the use of brain scans alone instead of brain scans plus preventive brain radiation affects lifespan in patients with small cell lung cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0006837
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 5
1 Disease Related Criteria
- Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC).
- Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal
disease. Patient also must not have a history of brain metastases or leptomeningeal disease.
2 Prior/Concurrent Therapy Criteria
- Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating physician. Patients with LS-SCLC must
have completed platinum-based chemotherapy and either definitive thoracic radiotherapy (including SBRT for early-stage T1-2 N0 M0 disease who do
not undergo surgery) or definitive surgical resection; thoracic radiation in addition to definitive surgical resection is allowed at the discretion of the
treating physician but is not required. Patients with ES-SCLC must have completed the platinum-based chemotherapy component of their treatment
course.
- All adverse events from prior treatment must have resolved to = Grade 2 (CTCAE Version 5.0) prior to randomization.
- Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. Systemic imaging (CT or PET/CT including the chest and abdomen) must be performed within 42 days prior to randomization.
- No more than 16 weeks may have elapsed between Day 1 of the last cycle of chemotherapy and randomization.
- Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy. Patients who have undergone prior stereotactic radiosurgery
for benign tumors or conditions (e.g., acoustic neuroma, grade I meningioma, trigeminal neuralgia) may be considered on a case-by-case basis. Please
contact Dr. Chad Rusthoven at chad.rusthoven@cuanschutz.edu for inquiries.
3 Clinical/Laboratory Criteria
-Patient must be = 18 years of age. (Korea = 19)
-Patient must have Zubrod Performance Status of 0-2 (see Section 10.9).
-Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies.
- Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
- Patient must not have other metastatic malignancies requiring current active treatment.
- Patient must not have any severe active comorbidities, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within 3 months prior to randomization
• Transmural myocardial infarction within 3 months prior to randomization
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of randomization
• Acute severe exacerbation of chronic obstructive pulmonary disease or other acute respiratory illness precluding study therapy at the time of
randomization
• Severe hepatic disease defined as a diagnosis of Child-Pugh class B or C hepatic disease
• HIV positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly
active antiretroviral therapy (HAART) and have a CD4 count = 200 cells/microliter within 16 weeks prior to randomization. Note also that HIV testing
is not required for eligibility for this protocol.
- Patient must not be pregnant because of fetal risks from radiation
Included in inclusion criteria
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method Cognitive failure-free survival(CFFS)