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Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical research trials and Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer. Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer clinical trial. Participants typically obtain the most effective healthcare available for their Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer  Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Chemotherapy Combined With 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 chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery.
Details: OBJECTIVES: - Determine the maximum tolerated dose of irinotecan administered with cisplatin and thoracic radiotherapy (given at two different schedules) in patients with limited stage small cell lung cancer. - Determine the qualitative and quantitative toxicity and non-dose-limiting toxicity of these regimens in these patients. - Determine the reversibility of all toxic effects associated with these regimens in these patients. OUTLINE: This is a non-randomized, dose-escalation study of irinotecan. Patients are assigned to 1 of 2 radiotherapy (RT) treatment groups. - Group I: Patients undergo thoracic RT twice daily, 5 days a week, for 3 weeks. - Group II: Patients undergo thoracic RT once daily, 5 days a week, for 7 weeks. - Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1 course for group I and 2 courses for group II. - Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses for group I and 2 courses, beginning after RT is complete, for group II. Sequential cohorts of 6 patients per group receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed every 3 months for 1 year and then 6 months for 4 years. PROJECTED ACCRUAL: A total of 12-36 patients (6-18 per group) 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 lung cancer by one of two methods: - Fine needle aspiration biopsy - Two positive sputa - Must have limited disease as defined by all of the following: - Stage I-IIIB - Confined to 1 hemithorax - No T4 tumor based on malignant pleural or pericardial effusion - Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed - No N3 disease based on contralateral hilar or contralateral supraclavicular involvement - Measurable or evaluable disease - Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise - No complete tumor resection - No pericardial effusion (regardless of cytology) PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 120,000/mm^3 Hepatic - Bilirubin no greater than 1.5 mg/dL - No known Gilbert's Disease Renal - Creatinine no greater than 1.5 mg/dL Cardiovascular - No myocardial infarction within the past 6 months - No symptomatic heart disease Pulmonary - FEV_1 at least 1.0 L/sec - No uncontrolled bronchospasms - No uncompensated chronic obstructive pulmonary disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No pre-existing peripheral neuropathy grade 2 or greater - No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix - No other serious concurrent medical illness PRIOR CONCURRENT THERAPY: Biologic therapy - No prior biologic therapy Chemotherapy - No prior chemotherapy Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy - No concurrent intensity-modulated radiotherapy Surgery - See Disease Characteristics Other - At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks - Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period - At least 14 days since prior Hypericum perforatum (St. John's wort) - No concurrent EIACDs - Concurrent gabapentin or other non-EIACDs allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CoreyLanger, Study Chair, Fox Chase Cancer Center
Dixie Regional Medical Center *Recruiting*
St. George, Utah, 84770
United States
Recruiting Ray Richards 801-688-4175
Providence Saint Joseph Medical Center - Burbank *Recruiting*
Burbank, California, 91505
United States
Recruiting Nancy Ellerbroek 818-847-3440
CCOP - Mount Sinai Medical Center *Recruiting*
Miami, Florida, 33140
United States
Recruiting Michael Samuels 305-674-2625
CCOP - Bay Area Tumor Institute *Recruiting*
Oakland, California, 94609-3305
United States
Recruiting Brenda Shank 510-456-8570
Akron General Medical Center *Recruiting*
Akron, Ohio, 44302
United States
Recruiting Mitchell Fromm 330-296-5019
Newark Beth Israel Medical Center *Recruiting*
Newark, New Jersey, 07112
United States
Recruiting Robert Ivker 201-926-7320
McKay-Dee Hospital Center *Recruiting*
Ogden, Utah, 84403
United States
Recruiting Contact Person 801-627-2800
Greenville Hospital System *Recruiting*
Greenville, South Carolina, 29605
United States
Recruiting Contact Person 864-455-700
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Maria Werner-Wasik 215-955-7679
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0385
United States
Recruiting William Mendenhall 352-265-0287
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Contact Person 919-419-5740
Cottonwood Hospital Medical Center *Recruiting*
Murray, Utah, 84107
United States
Recruiting Contact Person 801-314-5300
Sutter Health Western Division Cancer Research Group *Recruiting*
Greenbrae, California, 94904
United States
Recruiting David Irwin 415-925-7916
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting William Shipley 617-726-8146
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Christopher Koprowski 302-733-1830
Utah Valley Regional Medical Center - Provo *Recruiting*
Provo, Utah, 84604
United States
Recruiting Tarlton Blair 801-373-7850 ext. 2480
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Mark Bryer 573-882-2100
Fox Chase Cancer Center at St. Francis Medical Center *Recruiting*
Trenton, New Jersey, 08629
United States
Recruiting Jo Chalal 609-599-5179
Monmouth Medical Center *Recruiting*
Long Branch, New Jersey, 07740-6395
United States
Recruiting Smitha Gollamudi 732-923-6890
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center *Recruiting*
La Crosse, Wisconsin, 54601
United States
Recruiting Philip Doescher 608-782-7300 ext. 2588
Marlene and Stewart Greenebaum Cancer Center, University of Maryland *Recruiting*
Baltimore, Maryland, 21201
United States
Recruiting Mohan Suntharalingam 410-328-6080
Massachusetts General Hospital Cancer Center *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Contact Person 877-726-5130
Alta Bates Comprehensive Cancer Center *Recruiting*
Berkeley, California, 94704
United States
Recruiting Contact Peson 510-204-1591
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-5671
United States
Recruiting A.J. Cmelak 615-322-2555
Wendt Regional Cancer Center of Finley Hospital *Recruiting*
Dubuque, Iowa, 52001
United States
Recruiting Thomas Lally 319-589-2468
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Ritsuko Komaki 713-563-2328
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Michael Zurenko 864-241-6251
Cooper Cancer Institute at Cooper University Hospital *Recruiting*
Voorhees, New Jersey, 08043
United States
Recruiting Contact Person 800-826-6737
Wayne Memorial Hospital, Inc. *Recruiting*
Goldsboro, North Carolina, 27533
United States
Recruiting Contact Person 919-736-1110
Beebe Medical Center *Recruiting*
Lewes, Delaware, 19958
United States
Recruiting Contact Person 302-645-3770
California Pacific Medical Center - California Campus *Recruiting*
San Francisco, California, 94118-1618
United States
Recruiting Contact Person 415-600-6000
Additional Information:
Study ID Numbers: CDR0000269348; RTOG-0241
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00059761
Other Limited Stage Small Cell Lung Cancer Studies:
1. Tirapazamine Combined With Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
2. Amifostine to Prevent Side Effects in Patients Who Are Receiving Chemotherapy and Radiation Therapy for Limited-Stage Small Cell Lung Cancer
3. Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Small Cell Lung Cancer
4. Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
5. Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Related Studies:
Other limited stage small cell lung cancer Clinical Trials
Other Florida Clinical Trials
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Chemotherapy Combined With Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
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