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Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer
Overall Recruitment Status: Active, currently enrolling
Official Title
Randomized Phase II/III Trial of Prophylactic Cranial Irradiation With or Without Hippocampal Avoidance for Small Cell Lung Cancer
Region Sponsors
California - Northern
NRG Oncology
Acronym KP IRB No.
Study Type Phase
Clinical Trial Phase II
Study Population Description
Extensive Stage Small Cell Lung Carcinoma; Limited Stage Small Cell Lung Carcinoma; Small Cell Lung Cancer;
This randomized phase II/III trial studies how well whole-brain radiation therapy works and compares it with or without hippocampal avoidance in treating patients with small cell lung cancer that is found in one lung, the tissues between the lungs, and nearby lymph nodes only (limited stage) or has spread outside of the lung in which it began or to other parts of the body (extensive stage). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. The hippocampus is part of the brain that is important for memory. Avoiding the hippocampus during whole-brain radiation could decrease the chance of side effects on memory and thinking. It is not yet known whether giving whole-brain radiation therapy is more effective with or without hippocampal avoidance in treating patients with small cell lung cancer.
Detailed Description
Gender Age Limit
Male & Female
Inclusion Criteria
  • Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration
  • Patients must have a three-dimensional (3D), T1-weighted, spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan without and with gadolinium contrast-enhanced T1-weighted axial, coronal, and sagittal sequence acquisitions and standard T2-weighted axial and coronal fluid attenuation inversion recovery (FLAIR) sequence acquisitions within 28 days of Step 1 registration. To yield acceptable image quality. The pre-contrast-enhanced should have a resolution of 1 x 1 x 1.2 mm and should follow the protocols established by the Alzheimer's Disease Neuroimaging Initiative (ADNI). Performance of this sequence at a 3 Tesla field strength is recommended. Sites may contact the Imaging Co-Chair, Dr. Tammie Benzinger, for further information or assistance if needed. To yield acceptable image quality, the gadolinium contrast-enhanced T1-weighted scan should use the smallest possible axial slice thickness not exceeding 1.5 mm. The associated coronal and sagittal sequences can be up to 2.5 mm in slice thickness. This imaging is considered standard of care
  • Note: The MRI study as part of response assessment following chemotherapy can be used for this purpose, but the appropriate sequences must be obtained
  • this sequence cannot be obtained prior to chemotherapy and is mandatory irrespective of randomization to the experimental or control arm of this study
  • Patients must sign a study-specific informed consent prior to study entry
  • Please contact study personnel for more eligibility criteria
Exclusion Criteria
  • Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields
  • Radiographic evidence of CNS metastases
  • Radiographic evidence of hydrocephalus
  • Planned concurrent chemotherapy or anti-tumor agent during PCI Concomitant invasive malignancy or invasive malignancy within the past five years other than non-melanomatous skin cancer
  • history of in situ carcinoma (e.g. ductal carcinoma in situ of breast, in situ carcinoma of the cervix, vulva or larynx) is permitted
  • Contraindication to MR imaging, such as implanted metal devices or foreign bodies or severe claustrophobia
  • Women of childbearing potential and male participants who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Please contact study personnel for more eligibility criteria

Keywords and/or Specific Medical Conditions
  • Small Cell Lung Cancer
  • Oncology (Adult)
KP Clinical Facility
  • Central Valley-Modesto
  • Central Valley-Stockton
  • Diablo Medical Center-Deer Valley
  • Diablo Medical Center-Walnut Creek
  • Fremont Medical Center
  • Fresno Medical Center
  • Hayward Medical Center
  • Oakland Medical Center
  • Redwood City Medical Center
  • Roseville Medical Center
  • Roseville Medical Center-Rancho Cordova
  • Sacramento Medical Center
  • San Francisco Medical Center
  • San Leandro Medical Center
  • San Rafael Medical Center
  • Santa Clara Medical Center-Homestead
  • Santa Rosa Medical Center
  • Santa Teresa Medical Center-San Jose
  • South Sacramento Medical Center
  • South San Francisco Medical Center
  • Vallejo Medical Center
  • Vallejo Medical Center-Vacaville
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Samantha Seaward, MD
Contact Information:

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