CompletedPhase 2NCT01055197

Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

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.

Checked against the public recordLast updated Dec 12, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations115
SponsorRadiation Therapy Oncology Group
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Radiation Therapy Oncology Group
Interventions being studied
Radiation: Prophylactic Cranial Irradiation; Radiation: Radiation Therapy
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Arizona Oncology - TucsonTucson, Arizona
  • Saint Agnes Cancer Center at Saint Agnes Medical CenterFresno, California
  • Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California
  • Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado
  • Poudre Valley Radiation OncologyFort Collins, Colorado
  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut
  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain CampusNew Britain, Connecticut
  • University of Florida Shands Cancer CenterGainesville, Florida
  • Baptist Cancer Institute - JacksonvilleJacksonville, Florida
  • Integrated Community Oncology Network at Southside Cancer CenterJacksonville, Florida
  • Baptist Medical Center SouthJacksonville, Florida
  • Integrated Community Oncology NetworkJacksonville Beach, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 12, 2018. Always confirm current availability with the study team.

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