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

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ClinicalTrials.gov Identifier: NCT01055197
Recruitment Status : Completed
First Posted : January 25, 2010
Results First Posted : October 21, 2016
Last Update Posted : February 17, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: Prophylactic Cranial Irradiation Radiation: Radiation Therapy Phase 2

Detailed 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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : March 2010
Primary Completion Date : March 2015
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: PCI
Prophylactic Cranial Irradiation (PCI)
Radiation: Prophylactic Cranial Irradiation
Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.
Other Name: PCI
Experimental: PCI + Consolidation RT
Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Radiation: Prophylactic Cranial Irradiation
Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.
Other Name: PCI
Radiation: Radiation Therapy
Radiation Therapy (RT) to locoregional and residual metastatic disease in 15 once daily fractions of 3.0 Gy, 5 days per week, for a total of 45 Gy
Other Name: RT


Outcome Measures

Primary Outcome Measures :
  1. 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. ]
    Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months.


Secondary Outcome Measures :
  1. Comparison of Treatment-related Adverse Events [ Time Frame: From start of treatment to end of follow-up. ]
  2. 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. ]
  3. 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. ]
  4. Evaluation of the Percentage of the Planned Radiotherapy Dose to Each Site [ Time Frame: From start to end of radiation therapy. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055197


  Show 115 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Investigators
Principal Investigator: Elizabeth M. Gore, MD Medical College of Wisconsin
Principal Investigator: Alexander Sun, MD Princess Margaret Cancer Center
More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01055197     History of Changes
Other Study ID Numbers: RTOG 0937
CDR0000663959
NCI-2011-02008 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
First Posted: January 25, 2010    Key Record Dates
Results First Posted: October 21, 2016
Last Update Posted: February 17, 2017
Last Verified: December 2016

Keywords provided by Radiation Therapy Oncology Group:
extensive stage small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms