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
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Quynh-Thu Le, MD
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
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Maximilian Diehn, MD, PhD
Maximilian Diehn, MD, PhD

Jack, Lulu, and Sam Willson Professor and Professor of Radiation Oncology (Radiation Therapy)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Billy W Loo, Jr, MD PhD FASTRO FACR
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

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