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Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer Clinical research trials and Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer. Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer  Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
For Condition: Non-small cell lung cancer
Status: Suspended
Sponsor(s): Radiation Therapy Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage I, stage II, or stage III non-small cell lung cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage I-IIIB non-small cell lung cancer (phase I). - Determine the 12-month survival rate in patients treated with this regimen (phase II). - Determine the toxicity of this regimen in these patients. - Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen. - Determine the complete response rate in patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy. - Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 5-8 weeks. Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Cohorts of 7-9 patients receive escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose (MTD) is determined when given in combination with chemotherapy. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity. - Phase II: Additional patients are accrued and treated as above at the MTD. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 73 patients (27 for phase I and 46 for phase II) will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed unresectable stage I-IIIB non-small cell lung cancer - Squamous cell carcinoma - Adenocarcinoma - Large cell carcinoma - Non-small cell carcinoma not otherwise specified - All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields - Measurable disease on 3-dimensional planning CT scan - No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma - No stage IV or recurrent disease - No distant metastases or supraclavicular lymph node involvement - No significant atelectasis (i.e., atelectasis of an entire lung) - No pleural effusions, pericardial effusions, or superior vena cava syndrome - No prior lung cancer within the past 2 years - Ineligible for currently open RTOG phase III lung protocols PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin less than 1.5 mg/dL - AST less than 2 times upper limit of normal Renal: - Creatinine no greater than 2.0 mg/dL Pulmonary: - FEV_1 at least 1.0 L Other: - Not pregnant or nursing - Fertile patients must use effective contraception - No weight loss greater than 5% in the past 6 months - No other malignancy within the past year except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior biologic response modifiers for current lung cancer - At least 5 years since prior biologic response modifiers Chemotherapy: - No prior chemotherapy for current lung cancer - At least 5 years since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - No prior radiotherapy to the thorax Surgery: - No prior complete tumor resection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyBradley, Study Chair, Washington University Siteman Cancer Center
University of Texas Medical Branch
Galveston, Texas, 77555-0209
United States
Siteman Cancer Center
St. Louis, Missouri, 63110
United States
Latter Day Saints Hospital
Salt Lake City, Utah, 84143
United States
Northridge Hospital Medical Center
Northridge, California, 91328
United States
Gulf Coast Cancer Treatment Center
Panama City, Florida, 32405-4587
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
United States
Cancer Research for the Ozarks
Springfield, Missouri, 65807
United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410-1894
United States
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601
United States
University of Louisville
Louisville, Kentucky, 40292
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
United States
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
United States
McKay-Dee Hospital Center
Ogden, Utah, 84403
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
Radiation Medical Group, Incorporated
San Diego, California, 92101
United States
CCOP - Bay Area Tumor Institute
Oakland, California, 94609-3305
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Dixie Regional Medical Center
St. George, Utah, 84770
United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141-3098
United States
Foundation for Cancer Research and Education
Phoenix, Arizona, 85013
United States
Akron City Hospital - Summa Health System
Akron, Ohio, 44304
United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0385
United States
Cancer Care Center, Incorporated
Salem, Ohio, 44460
United States
Akron General Medical Center
Akron, Ohio, 44302
United States
Hematology Oncology Associates of Central New York, P.C. - Metro Center
Syracuse, New York, 13217-6962
United States
All Saints Cancer Center at All Saints Healthcare
Racine, Wisconsin, 53405
United States
Loyola University Medical Center
Maywood, Illinois, 60153
United States
MD Anderson Cancer Center Orlando
Orlando, Florida, 32806-2134
United States
Shands Cancer Center at the University of Florida - Gainesville
Gainesville, Florida, 32610-0232
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, 53226
United States
Cancer Treatment Center
Wooster, Ohio, 44691
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Additional Information:
Study ID Numbers: CDR0000068850; RTOG-L-0117
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023673
Other Non-Small Cell Lung Cancer Studies:
1. Combination Chemotherapy Plus Fluoxetine in Treating Patients With Advanced or Recurrent Non-Small Cell Lung Cancer
2. Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer
3. KRN7000 in Treating Patients With Solid Tumors
4. Phase I Study of IV DOTAP: Cholesterol-Fus1 in Non-Small-Cell Lung Cancer
5. Evaluation of efficacy, safety and tolerability of Targretin capsules in patients with advanced or metastatic non-small cell lung cancer
Related Studies:
Other Non-small cell lung cancer Clinical Trials
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Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
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