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

This study is currently recruiting participants.
Verified July 2013 by Radiation Therapy Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT01055197
First received: January 22, 2010
Last updated: July 16, 2013
Last verified: July 2013

January 22, 2010
July 16, 2013
March 2010
March 2015   (final data collection date for primary outcome 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. ] [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01055197 on ClinicalTrials.gov Archive Site
  • Comparison of treatment-related adverse events [ Time Frame: From start of treatment to end of follow-up. ] [ Designated as safety issue: Yes ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Evaluation of the percentage of the planned radiotherapy dose to each site [ Time Frame: From start to end of radiation therapy. ] [ Designated as safety issue: No ]
  • Comparison of treatment-related adverse events [ Designated as safety issue: Yes ]
  • Patterns of failure [ Designated as safety issue: No ]
  • Comparison of time to first failure [ Designated as safety issue: No ]
  • Evaluation of the percentage of the planned radiotherapy dose to each site [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer
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)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
  • Radiation: prophylactic cranial irradiation
    Given 5 days per week for 2 weeks
  • Radiation: selective external radiation therapy
    Given 5 days per week for 2-3 weeks
  • Experimental: Arm I
    Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.
    Intervention: Radiation: prophylactic cranial irradiation
  • Experimental: 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.
    Interventions:
    • Radiation: prophylactic cranial irradiation
    • Radiation: selective external radiation therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
Not Provided
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States,   Canada,   Israel
 
NCT01055197
RTOG 0937, CDR0000663959
Yes
Radiation Therapy Oncology Group
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Elizabeth M. Gore, MD Medical College of Wisconsin
Radiation Therapy Oncology Group
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP