N/A
N=20
Hippocampal Prophylactic Cranial Irradiation for Small Cell Lung Cancer
Small-cell Lung Cancer · SCLC · Small Cell Lung Cancer Limited Stage
Bottom Line
View on ClinicalTrials.gov: NCT01797159 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall — 7.45; 7.06; 7.36 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hippocampal-sparing Prophylactic Cranial Irradiation (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Hippocampal-sparing Prophylactic Cranial Irradiation (PCI) on Possible Delayed Recall Toxicity as Assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R) for Delayed Recall |
7.45; 7.06; 7.36 | — |
| SECONDARY Compare Cognitive Function Following Sparing PCI to That of Standard PCI |
21.5; 7.36; 10.6; 29.6; 101.2; 34.2 | — |
| SECONDARY Compare Cognitive Function Following Sparing PCI to That of Standard PCI |
21.5; 7.36; 10.6; 29.6; 101.2; 34.2 | — |
| SECONDARY Compare Cognitive Function Following Sparing PCI to That of Standard PCI |
21.5; 7.36; 10.6; 29.6; 101.2; 34.2 | — |
| SECONDARY Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire (QLQ)-C30 |
11.1; -9.5; 20; 6.7; 0; 2.4 | — |
| SECONDARY Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment QLQ-C30 |
2.8; -5.6; -3; 0; 2.8; 2.8 | — |
| SECONDARY Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Quality of Life Questionnaire-Brain Cancer (QLQ-BN20) |
13.3; -4.4; 0; 2.2; 6.7; 13.3 | — |
| SECONDARY Compare Change in Quality of Life of Hippocampal-sparing PCI Treatment Outcome to Standard PCI Treatment Using the Quality of Life Questionnaire-Brain Cancer (QLQ-BN20). |
9.1; -3; -6.1; -15.2; 9.1; 6.1 | — |
| SECONDARY Number Participants With Hippocampus Brain Metastases Following Sparing PCI |
4 | — |
| SECONDARY Assess if Development of Leptomeningeal Carcinomatosis Following Sparing PCI is Higher Than Expected |
— | — |
| SECONDARY Percentage of Participants Surviving Following Hippocampal-sparing PCI |
88 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01797159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.