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Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00066222
Recruitment Status : Completed
First Posted : August 7, 2003
Results First Posted : December 18, 2014
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Tracking Information
First Submitted Date  ICMJE August 6, 2003
First Posted Date  ICMJE August 7, 2003
Results First Submitted Date  ICMJE December 10, 2014
Results First Posted Date  ICMJE December 18, 2014
Last Update Posted Date December 22, 2017
Study Start Date  ICMJE June 2003
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
Overall Survival at 2 Years [ Time Frame: From registration to 2 years ]
Survival time is defined as time from study registration to the date of death from any cause and survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00066222 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2017)
  • Overall Survival (OS) and Progression-free Survival (PFS) at 1 Year [ Time Frame: From registration to one year. ]
    An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.
  • Median Overall Survival Time and Progression-free Survival Time [ Time Frame: From registration to 2 years ]
    An event for overall survival is death due to any cause. Overall survival time is defined as time from study registration to the date of death from any cause. An event for progression-free survival is the first of the following: local progression, regional progression, distant metastases, or death due to any cause. Progression-free survival time is defined as time from study registration to the date of first failure. For both outcome measures, patients last known to be alive without failure are censored at the date of last contact. Survival rates are estimated by the Kaplan-Meier method.
  • Number of Patients With Acute Treatment-related Grade 3 or 4 Esophagitis [ Time Frame: From start of radiation therapy until 90 days following the start of radiation therapy ]
    Highest grade treatment-related toxicity per subject was counted. Toxicities were graded using Common Toxicity Criteria (CTC) v 2.0. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening or disabling, Grade 5= Death related to toxicity.
  • Frequency of Treatment-related Fatalities at 2 Years [ Time Frame: From the start of treatment to 2 years ]
    A treatment-related fatality was any death judged to be related to protocol treatment.
  • Tumor Response [ Time Frame: From the start of treatment to 2 months following the completion of chemotherapy ]
    Response will be recorded as the best response observed two months after the completion of chemoradiation therapy. Tumor response as defined by Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions as measured by MRI, CT, or physical examination (this is the order of preference for measurement). Partial Response (PR): >= 30% decrease in the sum of the longest diameter (LD) of target lesions (order of preference for measurement is MRI, CT, physical examination). Progressive Disease (PD): >= 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions (order of preference for measurement is MRI, CT, physical examination). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Official Title  ICMJE A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin and etoposide together with radiation therapy works in treating patients with limited-stage small cell lung cancer.

Detailed Description

OBJECTIVES:

  • Determine the response rate of patients with limited stage small cell lung cancer treated with cisplatin and etoposide combined with accelerated high-dose thoracic radiotherapy.
  • Determine the progression-free and overall survival in patients treated with this regimen.
  • Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

OUTLINE: Patients undergo radiotherapy once daily 5 days a week for approximately 3 weeks and then twice daily 5 days a week for approximately 2 weeks (a total of 9 treatment days during the final 2-week treatment period). Beginning on the first day of radiotherapy, patients receive cisplatin IV over 2 hours and etoposide IV over 1 hour on day 1 and oral etoposide once daily on days 2 and 3. Chemotherapy repeats every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 18 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lung Cancer
Intervention  ICMJE
  • Drug: Cisplatin
    60 mg/m2 given intravenously. During RT, give on day 1 and day 22. After completion of RT, on days 43 and 64.
  • Drug: Etoposide
    120 mg/m2 given intravenously. During RT, give on days 1-3, then days 22-24. After completion of RT, on days 43-45 and days 64-66.
  • Radiation: Radiation therapy
    Large field 28.8 Gy: 1.8 Gy per fraction, 5 days per week for 16 fractions. On days 23-26, BID: use anteroposterior and posteroanterior (AP/PA) fields in a.m. at 1.8 Gy per fraction; boost with 2nd treatment in p.m. at 1.8 Gy per fraction. Then off-cord boost, 1.8 Gy, BID, x last 5 days for a total dose of 61.2 Gy in 5 wks.
Study Arms  ICMJE Experimental: Radiation Therapy + Chemotherapy
Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
Interventions:
  • Drug: Cisplatin
  • Drug: Etoposide
  • Radiation: Radiation therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2013)
72
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell carcinoma of the lung by fine needle aspiration biopsy or two positive sputa
  • Must have limited disease

    • Stage I, II, IIIA, or IIIB

      • Confined to 1 hemithorax, but excluding the following:

        • T4 tumor based on malignant pleural effusion
        • N3 disease based on contralateral hilar or contralateral supraclavicular involvement
  • No pericardial or pleural effusions on chest x-ray (regardless of cytology)
  • Measurable or evaluable disease
  • Tumor must be able to be encompassed by limited radiotherapy fields without significantly compromising pulmonary function
  • No prior complete tumor resection

PATIENT CHARACTERISTICS:

Age

  • 18 to 100

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 150,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 mg/dL

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • No myocardial infarction within the past 6 months
  • No symptomatic heart disease

Pulmonary

  • No chronic obstructive pulmonary disease with Forced Expiratory Volume (FEV)-1 no greater than 0.8 liter
  • No uncontrolled bronchospasm in the unaffected lung

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Available for follow-up
  • No other malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or non-invasive in situ malignancies
  • No other concurrent serious medical illness
  • No uncontrolled psychiatric illness
  • No chronic alcohol or drug abuse

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the chest or other area containing a large amount of bone marrow (e.g., more than 75% of pelvic bone)

Surgery

  • See Disease Characteristics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00066222
Other Study ID Numbers  ICMJE RTOG-0239
CDR0000271939
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Radiation Therapy Oncology Group
Study Sponsor  ICMJE Radiation Therapy Oncology Group
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Ritsuko U. Komaki, MD, FACR M.D. Anderson Cancer Center
PRS Account Radiation Therapy Oncology Group
Verification Date November 2017

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