Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer
The Investigators are looking to compare standard treatment for the management of small cell lung cancer (SCLC) which is prophylactic cranial Irradiation (PCI) (shown to be very good in patient survival) with cranial sparing PCI. Although standard of care PCI is successful in patient survival it also has neurologic side-effects. The Investigators are hoping the cranial sparing PCI has the same positive survival results with the added benefit of lowering neurological side-effects.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 18, 2021 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Interventions being studied
- Radiation: Hippocampal-sparing Prophylactic Cranial Irradiation
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Patient must have newly diagnosed and confirmed small-cell lung cancer (SCLC)
- Patient must have a performance status of 1 or higher
- Patients must not have received previous irradiation to the brain
- Patients must have limited stage disease with complete response to chemotherapy and consolidative chest radiotherapy that was documented at least on standard chest x-rays within one month of study entry
- Negative MRI or CT scan of the brain at least one month before protocol entry
- Women of child-bearing potential must have a negative pregnancy test and also agree to use adequate contraceptives while on protocol
- Patient must be able to understand and sign the informed consent document
- Patient must be informed of the investigational aspect to this trial prior to singing the informed consent document
- Patients receiving prior external beam irradiation to the head or neck, including any form of stereotactic irradiation
- Radiographic evidence of brain metastases and/or ipsilateral lung metastases/malignant pleural effusion
- Planned concurrent chemotherapy or antitumoral agent during PCI
- Concomitant malignancy or malignancy within the past five years other than nonmelanomatous skin cancer or carcinoma in situ of the cervix
- Patients with minimal pleural effusion evident on chest X-ray; minimal pleural effusion visible on chest CT is allowed.
- Patients with epilepsy requiring permanent oral medication
- Patients must not have a serious medical or psychiatric illness that would, in the opinion of the investigator, prevent informed consent or completion of protocol treatment, and/or follow-up visits.
- Patients may not take Memantine. This is the only eligibility criterion that has been added to those of RTOG 0212, since some physicians might now prescribe Memantine. This medication would not have been given at the time of enrollment on RTOG 0212 and its administration could confound the results of this study.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Bayview Medical CenterBaltimore, Maryland
- The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 18, 2021. Always confirm current availability with the study team.