Randomized Phase II/III Trial of Prophylactic Cranial Irradiation with or without Hippocampal Avoidance for Small Cell Lung Cancer

February 22, 2021

Clinical Trial Information

Protocol – NRG – CC003


Please Note – Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.


  1. Histologic proof or unequivocal cytologic proof (fine needle aspiration, biopsy or two positive sputa) of SCLC within 250 days prior to Step 1 registration. High-grade neuroendocrine carcinoma or combined SCLC and NSCLC is permitted.
  2. Patients must be registered to Step 1 registration no earlier than 7 days and no later than 56 days after completing chemotherapy. NOTE:
    1. Post-chemotherapy restaging imaging must be completed no more than 56 days prior to Step 1 registration.
    2. For patients with extensive-stage small cell lung cancer who are being considered for consolidative thoracic radiotherapy after chemotherapy, concomitant administration of consolidative thoracic radiotherapy and protocol-specified prophylactic cranial irradiation with or without hippocampal avoidance is permitted.
  3. Patients must have a gadolinium contrast-enhanced three-dimensional (3D), spoiled gradient (SPGR), magnetization-prepared rapid gradient echo (MP-RAGE), or turbo field echo (TFE) MRI scan (see section 11.3 regarding axial T2/FLAIR sequence). To yield acceptable image quality, the gadolinium contrast-enhanced three-dimensional SPGR, MP-RAGE or TFE axial MRI scan must use the smallest possible axial slice thickness not exceeding 1.5 mm. Sites may contact the Imaging Co-Chairs for further information or assistance if needed. This MRI must be obtained within 56 days prior to Step 1 registration.
  4. Prior to chemotherapy +/- thoracic radiotherapy, patients must be defined as limited-stage or extensive-stage SCLC after clinical staging evaluation involving the following:
    a. History/physical examination;
    b. CT of the chest and abdomen with contrast (does not have to be done if the patient has had a PET/CT scan prior to initiating chemotherapy or thoracic radiotherapy);
    c. MRI of the brain with contrast or diagnostic head CT with contrast;
    d. For patients without evidence of extensive-stage SCLC on chest and abdomen CT and brain MRI or head CT, a PET/CT or bone scan is required to confirm limited-stage SCLC.
  5. After chemotherapy, patients must be restaged prior to Step 1 registration using the same diagnostic work-up as required pre-chemotherapy (see Section 3.2.4). Repeat PET/CT or bone scan is not required. Patients must have:
    • History/physical examination within 30 days of Step 1 registration;
    • No CNS metastases (Repeat MRI required; see Section 3.2.3 for details) within 56 days prior to Step 1 registration;
    • No progression in any site;
    • Radiographic partial or complete response to chemotherapy in at least one disease site within 56 days prior to Step 1 registration.
    o If PET/CT was obtained prior to chemotherapy, either a repeat PET/CT or CT of the chest and abdomen with contrast can be obtained for response assessment.
    o Patients who underwent resection for limited-stage SCLC prior to chemotherapy and have no radiographically evident disease for response assessment remain eligible if post-chemotherapy imaging demonstrates no progression.
  6. Zubrod performance status 0-2 within 30 days prior to Step 1 registration.
  7. Age ≥18.

Genesys Hurley Cancer Institute

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Flint, MI 48503

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Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium


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