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

This study is ongoing, but not recruiting participants.
Study NCT00066222.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Official Title  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 Phase Phase II
Study Type  Interventional
Study Design  Treatment, Open Label
Primary Outcome Measure  Overall survival at 1 and 2 years [ Designated as safety issue: No ]
Progression-free survival and median survival time at 1 year [ Designated as safety issue: No ]
Treatment-related and rate of treatment-related fatalities at 2 years [ Designated as safety issue: No ]
Response rates (complete response, partial response, progressive disease, and stable disease) 2 months after completion of study treatment [ Designated as safety issue: No ]
Secondary Outcome Measure 
Condition  Lung Cancer
Intervention  Drug: cisplatin
Drug: etoposide
Procedure: adjuvant therapy
Procedure: radiation therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  71
Start Date  June 2003
Completion Date
Eligibility Criteria 

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 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 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
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00066222
Organization ID CDR0000271939
Secondary IDs †† RTOG-0239
Study Sponsor  Radiation Therapy Oncology Group
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Ritsuko U. Komaki, MD, FACR     M.D. Anderson Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date May 2006
First Received Date  August 6, 2003
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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