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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.

Sponsors and Collaborators: Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066222
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Procedure: adjuvant therapy
Procedure: radiation therapy
Phase II

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Etoposide    Cisplatin    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment:   71
Study Start Date:   June 2003

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066222

Show 104 study locations  Show 104 Study Locations

Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Ritsuko U. Komaki, MD, FACR     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:
Komaki R, Moughan J, Ettinger D, et al.: Toxicities in a phase II study of accelerated high dose thoracic radiation therapy (TRT) with concurrent chemotherapy for limited small cell lung cancer (LSCLC) (RTOG 0239). [Abstract] J Clin Oncol 25 (Suppl 18): A-7717, 438s, 2007.
 

Study ID Numbers:   CDR0000271939, RTOG-0239
First Received:   August 6, 2003
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00066222
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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