Radiation Therapy in Treating Patients with Extensive Stage Small Cell Lung Cancer
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Scottsdale/Phoenix, Arizona: 13-008329
NCT ID: NCT01055197
Sponsor Protocol Number: RTOG 0937
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- 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
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Steven Schild, M.D.
Closed for enrollment
Cancer Center Clinical Trials Referral Office