Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 100 NCI RTOG-0239 NCT00066222

Objectives

1. 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.
2. Determine the progression-free and overall survival in patients treated with this regimen.
3. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 to 100

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count at least 1,500/mm³
• Platelet count at least 150,000/mm³

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 FEV₁ 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

Expected Enrollment

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

Outcomes

Overall survival at 1 and 2 years
Progression-free survival and median survival time at 1 year
Treatment-related and rate of treatment-related fatalities at 2 years
Response rates (complete response, partial response, progressive disease, and stable disease) 2 months after completion of study treatment

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.

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.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Ritsuko Komaki, MD, FACR, Protocol chair		Ph: 713-563-2328; 800-392-1611 Email: rkomaki@mdanderson.org

Registry Information
Official Title		A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer
Trial Start Date		2003-06-20
Registered in ClinicalTrials.gov		NCT00066222
Date Submitted to PDQ		2003-01-09
Information Last Verified		2006-05-17
NCI Grant/Contract Number		CA21661

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