Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
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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 Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Of Accelerated High Dose Thoracic Irradiation With Concurrent Chemotherapy For Patients With Limited Small Cell Lung Cancer |
- 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 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
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 |
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
Show 104 Study Locations| Study Chair: | Ritsuko U. Komaki, MD, FACR | M.D. Anderson Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00066222 History of Changes |
| Other Study ID Numbers: | CDR0000271939, RTOG-0239 |
| Study First Received: | August 6, 2003 |
| Last Updated: | July 11, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
limited stage small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Etoposide phosphate Cisplatin Etoposide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013