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

SCHEMA NRG CC003

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

Eligibility:

  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.

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