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Home > "C" Clinical Trials Conditions > Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

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



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

For Condition: limited stage small cell lung cancer
Status: Recruiting
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: 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: Phase II trial to study the effectiveness of combining cisplatin and etoposide with radiation therapy in treating patients who have limited-stage small cell lung cancer.
Details: 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. 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol 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 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 prior or concurrent malignancy 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
RitsukoKomaki,  Study Chair,  M.D. Anderson Cancer Center

University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham,  Alabama,  35294-3300
United States
Recruiting Ruby  Meredith 205-934-4763

Lankenau Cancer Center at Lankenau Hospital *Recruiting*
Wynnewood,  Pennsylvania,  19096
United States
Recruiting Contact  Person 610-645-2680

St. Louis University Hospital Cancer Center *Recruiting*
St. Louis,  Missouri,  63110-0250
United States
Recruiting Oscar  Norton 314-577-8815

Fox Chase Cancer Center at St. Francis Medical Center *Recruiting*
Trenton,  New Jersey,  08629
United States
Recruiting Jo  Chalal 609-599-5179

Utah Valley Regional Medical Center - Provo *Recruiting*
Provo,  Utah,  84604
United States
Recruiting Tarlton  Blair 801-373-7850 ext. 2480

Miami Valley Hospital *Recruiting*
Dayton,  Ohio,  45409
United States
Recruiting Contact  Person 937-208-346

CCOP - Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-395-8678

Bryn Mawr Hospital *Recruiting*
Bryn Mawr,  Pennsylvania,  19010
United States
Recruiting Contact  Person 610-526-3686

Wendt Regional Cancer Center of Finley Hospital *Recruiting*
Dubuque,  Iowa,  52001
United States
Recruiting Thomas  Lally 319-589-2468

Good Samaritan Hospital *Recruiting*
Dayton,  Ohio,  45406-1891
United States
Recruiting Contact  Person 937-278-2612

Kettering Medical Center *Recruiting*
Kettering,  Ohio,  45429
United States
Recruiting Contact  Person 937-296-7246

CCOP - Bay Area Tumor Institute *Recruiting*
Oakland,  California,  94609-3305
United States
Recruiting Brenda  Shank 510-456-8570

CCOP - MainLine Health *Recruiting*
Wynnewood,  Pennsylvania,  19096
United States
Recruiting Albert  DeNittis 610-645-2433

LDS Hospital *Recruiting*
Salt Lake City,  Utah,  84143
United States
Recruiting William  Sause 801-408-1146

Paoli Memorial Hospital *Recruiting*
Paoli,  Pennsylvania,  19301-1792
United States
Recruiting Contact  Person 610-648-1637

Cottonwood Hospital Medical Center *Recruiting*
Murray,  Utah,  84107
United States
Recruiting Contact  Person 801-314-5300

McKay-Dee Hospital Center *Recruiting*
Ogden,  Utah,  84403
United States
Recruiting Contact  Person 801-627-2800

Foundation for Cancer Research and Education *Recruiting*
Phoenix,  Arizona,  85013
United States
Recruiting David  Brachman 602-274-4484

Dixie Regional Medical Center *Recruiting*
St. George,  Utah,  84770
United States
Recruiting Ray  Richards 801-688-4175

Grandview Hospital *Recruiting*
Dayton,  Ohio,  45405
United States
Recruiting Contact  Person 937-226-3200

Cancer Treatment Center *Recruiting*
Cincinnati,  Ohio,  45206
United States
Recruiting Contact  Person 513-569-6414

Cancer Care Center, Incorporated *Recruiting*
Salem,  Ohio,  44460
United States
Recruiting Contact  Person 330-375-3557

Greene Memorial Hospital *Recruiting*
Xenia,  Ohio,  45385
United States
Recruiting Contact  Person 937-226-3200

Akron City Hospital *Recruiting*
Akron,  Ohio,  44304
United States
Recruiting William  Demas 330-375-3557

West Michigan Cancer Center *Recruiting*
Kalamazoo,  Michigan,  49007
United States
Recruiting Contact  Person 616-373-7488

Middletown Regional Hospital *Recruiting*
Middletown,  Ohio,  45044
United States
Recruiting Contact  Person 513-424-2111

Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha *Recruiting*
Omaha,  Nebraska,  68114-4199
United States
Recruiting James  Wheeler 402-354-4104

CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield,  Wisconsin,  54449
United States
Recruiting Tarit  Banerjee 715-387-5134


Additional Information:
Study ID Numbers:
  CDR0000271939;  RTOG-0239
Study Start Date: 
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066222

Other Limited Stage Small Cell Lung Cancer Studies:
1. Cisplatin and Irinotecan Followed by Carboplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

2. Diagnosis and Treatment Planning in Patients Suspected of Having Lung Cancer

3. Captopril in Treating Patients With Non-Small Cell Lung Cancer or Limited-Stage Small Cell Lung Cancer That Has Been Previously Treated With Radiation Therapy With or Without Chemotherapy

4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer

5. Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

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