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Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed Clinical research trials and Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed  Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
For Condition: stage 3A non-small cell lung cancer,squamous cell lung cancer,adenocarcinoma of the lung,large cell lung cancer,stage 3B non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
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 drug with either standard radiation therapy or radiation therapy given at different times may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and carboplatin, plus either standard radiation therapy or radiation therapy given at different times, in treating patients with stage III non-small cell lung cancer that cannot be surgically removed.
Details: OBJECTIVES: I. Determine response rates, duration of response, and survival of patients with unresectable or regionally advanced (M0) stage IIIA or IIIB non-small cell lung carcinoma treated with induction paclitaxel and carboplatin followed by conventional vs accelerated radiation. II. Evaluate the patterns of local and distant failure for patients treated with these regimens. PROTOCOL OUTLINE: Patients are stratified by histology (squamous vs nonsquamous), performance status (0 vs 1), disease stage (IIIA vs IIIB), and response to induction chemotherapy (initial response vs no response). All patients receive induction therapy consisting of paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on days 1 and 22. Treatment repeats every 42 days for 2 courses. Patients whose disease has not progressed outside the thorax are then randomized to 1 of 2 treatment arms. Arm I: Patients receive standard radiotherapy once a day, 5 days a week for 6-7 weeks. Arm II: Patients receive hyperfractionated accelerated radiotherapy 3 times daily, 5 days a week over 2.5 weeks. Each fraction is separated by a minimum of 4 hours. Radiotherapy begins between days 43 and 50. Patients are followed at 1 month after radiotherapy, then every 3 months for 2 years, every 6 months for the next 3 years, and annually thereafter. PROJECTED ACCRUAL: Approximately 294 patients will be accrued for this study within 3.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed unresectable stage IIIA or IIIB non-small cell carcinoma of the lung; Adenocarcinoma; Squamous cell carcinoma; Anaplastic large cell carcinoma - Stage IIIA patients must not be candidates for resection after neoadjuvant therapy (unresectable T3N1 or T1-3 primary tumors with metastasis limited to the ipsilateral mediastinal and subcarinal lymph nodes); Mediastinotomy or thoracoscopy required for potentially resectable IIIa disease when ipsilateral mediastinal lymph nodes are less than 2 cm - Stage IIIB patients must not have significant pleural effusion (seen on CT scan only OR does not reaccumulate after one thoracentesis and is cytologically negative); Metastases to contralateral mediastinal or supraclavicular nodes allowed - Measurable or evaluable disease - No distant metastasis or significant pleural effusion --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior systemic chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior thoracic radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: At least 12 weeks - Hematopoietic: WBC at least 3,500/mm3; Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin less than 1.5 mg/dL; SGOT no greater than 2 times normal; No liver disease with significant hepatic insufficiency - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min - Cardiovascular: No cardiac arrhythmia or end stage congestive heart failure - Neurologic: No preexisting clinically significant peripheral neuropathy; No organic brain syndrome - Other: No history of prior or concurrent malignancy in the past 5 years except: Surgically cured basal cell carcinoma of the skin; Carcinoma in situ of the cervix; Not pregnant; Fertile patients must use effective contraception during and for 2 weeks after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ChandraBelani, Study Chair, Eastern Cooperative Oncology Group
Community Medical Center
Toms River, New Jersey, 08755
United States
St. Francis Medical Center
Trenton, New Jersey, 08629
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Trinitas Hospital - Jersey Street Campus
Elizabeth, New Jersey, 07201
United States
Overlook Hospital
Summit, New Jersey, 07902-0220
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Additional Information:
Study ID Numbers: CDR0000066107; E-2597,CTSU
Study Start Date: April 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003235
Other Stage 3a Non-Small Cell Lung Cancer Studies:
1. Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Non-Small Cell Lung Cancer
2. Combination Chemotherapy Plus Radiation Therapy With or Without AE-941 in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
3. Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
4. Cetuximab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Unresectable Stage IIIA or Stage IIIB Non-Small Cell Lung Cancer
5. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
Related Studies:
Other stage 3A non-small cell lung cancer Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Can Not Be Surgically Removed
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