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

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Etoposide; Radiation: Radiation therapy; Drug: Cisplatin

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00066222

RTOG-0239

CDR0000271939

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

72 participants in 1 patient group

Radiation Therapy + Chemotherapy

Experimental group

Description:

Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy

Treatment:

Drug: Etoposide

Drug: Cisplatin

Radiation: Radiation therapy