Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments prophylactic cranial irradiation, selective external radiation therapy
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date March 2010
End date March 2015
Trial size 154 participants
Trial identifier NCT01055197, CDR0000663959, NCI-2011-02008, RTOG 0937

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.
prophylactic cranial irradiation
Given 5 days per week for 2 weeks
(Experimental)
Patients undergo prophylactic cranial irradiation as in arm I. Patients also undergo consolidative extracranial radiotherapy to locoregional and residual metastatic disease 5 days per week for 2-3 weeks.
prophylactic cranial irradiation
Given 5 days per week for 2 weeks
selective external radiation therapy
Given 5 days per week for 2-3 weeks

Primary Outcomes

Measure
Overall survival
time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.

Secondary Outcomes

Measure
Comparison of treatment-related adverse events
time frame: From start of treatment to end of follow-up.
Patterns of failure
time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.
Comparison of time to first failure
time frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 12 months.
Evaluation of the percentage of the planned radiotherapy dose to each site
time frame: From start to end of radiation therapy.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Principal investigator Elizabeth M. Gore, MD
Description OBJECTIVES: Primary - To compare the 1-year overall median survival rate in patients with extensive stage small cell lung cancer treated with prophylactic cranial irradiation with vs without consolidative extracranial radiotherapy following platinum-based chemotherapy. Secondary - To compare treatment-related adverse events in these patients. - To evaluate patterns of failure in these patients. - To compare the time to first failure in these patients. - To evaluate the percentage of the planned radiotherapy dose given to each site. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment (complete response vs partial response) and number of metastatic lesions (1 vs 2-3). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks. - Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also undergo consolidative extracranial radiotherapy to locoregional and residual metastatic disease 5 days per week for 2-3 weeks. After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and 12 months; every 6 months for 2 years; and then annually thereafter.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.