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Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
Not Recruiting
Trial ID: NCT01055197
Purpose
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an
effective treatment for extensive stage small cell lung cancer.
PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain
works when given with or without radiation therapy to other areas of the body in treating
patients with extensive stage small cell lung cancer.
Official Title
Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)
Stanford Investigator(s)
Heather Wakelee
Winston Chen and Phyllis Huang Professor
Quynh-Thu Le, MD
Katharine Dexter McCormick and Stanley McCormick Memorial Professor and Professor, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS)
Joel Neal, MD, PhD
Associate Professor of Medicine (Oncology)
Maximilian Diehn, MD, PhD
Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)
Kavitha Ramchandran
Clinical Professor, Medicine - Oncology
Billy W Loo, Jr, MD PhD FASTRO FACR
Professor of Radiation Oncology (Radiation Therapy)
Eligibility
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed extensive stage small cell lung cancer
(SCLC) diagnosed within the past 6 months*
- Has 1-4 extracranial metastatic lesions NOTE: *Diagnosis made before treatment
with chemotherapy
- Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND
meets the following criteria:
- Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease
according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (if
radiotherapy has been delivered to primary disease with chemotherapy, there must
be complete or partial response in ≥ 1 of the sites that has not been treated
with radiotherapy)
- No progression in any site
- No limited stage SCLC, even if disease progressed
- No brain or central nervous system (CNS) metastases
PATIENT CHARACTERISTICS:
- Zubrod performance status 0-2
- Absolute neutrophil count (ANC) ≥ 1,000/mm^3
- Platelets ≥ 75,000/mm^3
- Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed)
- Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times
upper limit of normal (ULN) (for patients who will receive radiotherapy to the liver)
- Serum bilirubin < 1.5 times ULN (for patients who will receive radiotherapy to the
liver)
- Serum creatinine < 1.5 times ULN (for patients who will receive radiotherapy to the
kidneys)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No severe, active co-morbidity, defined as any of the following:
- Acute bacterial or fungal infection requiring IV antibiotics at the time of study
registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of study
registration
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 [except for neuropathy
and alopecia])
- Thoracic radiotherapy administered concurrently with or before chemotherapy for the
current diagnosis allowed (these patients will not receive mediastinal radiotherapy
per protocol)
- No prior radiotherapy to the region of this cancer that would result in overlap of
radiotherapy fields
- No concurrent chemotherapy
Intervention(s):
radiation: prophylactic cranial irradiation
radiation: Radiation Therapy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061