February 22, 2021 Lung Small Cell Lung Cancer

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.


Clinical Trial Information

PROTOCOL: NRG-LU005

SCHEMA NRG LU005

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

ELIGIBILITY:

  1. Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0), within 60 days prior to registration.
  2. Patients must have received one pre-registration cycle of platinum/etoposide chemotherapy prior to study entry, with study registration required within 21 days from day 1 of the pre-registration cycle of chemotherapy and protocol treatment designed to
    begin 21 days after. If patient has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted.
  3. Patients must have had measurable disease.
  4. Age ≥ 18.
  5. ECOG Performance Status of 0-2 within 30 days prior to registration.
  6.   Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging.
  7.  No definitive clinical or radiologic evidence of metastatic disease.
  8.  No definitive surgical resection of small cell lung cancer.
  9.  No prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all
    permissible).
  10. No more than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment. Note that prior chemotherapy for a different cancer is allowable. No prior Atezolizumab or other immunotherapy agent.
  11.  No prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study PIs.
  12. Patients with cytologically positive pleural or pericardial fluid are not eligible.

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