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



Status:Completed
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/24/2017
Start Date:June 2003
End Date:November 2013

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A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer

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.

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.

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
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