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Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer Clinical research trials and Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer. Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer  Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer
Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer
For Condition: Carcinoma, Small Cell
Status: No longer recruiting
Sponsor(s): Medical Research Council ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug is a way to kill more tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effect of two combination chemotherapy regimens followed by radiation therapy in treating patients with small cell lung cancer.
Details: OBJECTIVES: I. Compare the survival rate in patients with newly diagnosed small cell lung cancer and good performance status treated with an intensive regimen of ifosfamide/carboplatin/etoposide with mid-cycle vincristine (VICE) vs. standard chemotherapy followed, as feasible, by thoracic radiotherapy. II. Compare the adverse effects of treatment and quality of life (including psychological distress, physical status, and functional status and global quality of life) in these patients. III. Compare the Rotterdam Symptom Checklist vs. the EORTC QLQ-C30 and LC13 quality-of-life questionnaires in relation to compliance and ability to detect differences between treatments. PROTOCOL OUTLINE: This is a randomized study. The first group receives standard combination chemotherapy with doxorubicin/cyclophosphamide/etoposide (ACE) or cisplatin/etoposide (PE) every 3 weeks for 6 courses. The second group receives intensive combination chemotherapy with carboplatin/ifosfamide/etoposide on days 1-3 with vincristine on day 14 (VICE). Courses repeat every 4 weeks for 6 courses. Patients in both groups are considered for thoracic radiotherapy beginning 4-5 weeks after the first day of the last course of chemotherapy. Concurrent prophylactic antibiotics should be given. Patients who relapse may receive further treatment at the clinician's option. Patients are followed monthly for 6 months, every 2 months for up to 1 year, every 3 months for up to 2 years, every 6 months for 5 years, and annually thereafter. PROJECTED ACCRUAL: A total of 400 patients will be entered over 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Microscopically proven small cell lung cancer - Diagnosis based on bronchial, mediastinal, pleural, lung, or lymph node biopsy, sputum cytology, or bronchial brushing or fine needle aspirate cytology - No pleural fluid cytology --Prior/Concurrent Therapy-- No prior therapy --Patient Characteristics-- Age: Any age Performance status: WHO 0-2 Hematopoietic: - WBC more than 3,000 - ANC more than 1,500 - Platelets more than 100,000 Hepatic/Renal: - Alkaline phosphatase, aminotransferase, sodium, and LDH normal or no more than 1 of them abnormal - Creatinine or urea normal - Creatinine clearance or GFR more than 65 mL/min Other: - No clinical evidence of infection - No prior or concurrent malignancy that interferes with protocol treatments or comparisons - No other condition that contraindicates treatment - Willing and able to complete quality-of-life questionnaires (Hospital Anxiety and Depression Scale, Rotterdam Symptom Checklist, and EORTC questionnaires completed prior to randomization)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidGirling, Study Chair, Medical Research Council
Medical Research Council Clinical Trials Unit
London, England, NW1 2DA
United Kingdom
Additional Information:
Study ID Numbers: CDR0000064998; MRC-LU21,EU-96019
Study Start Date: March 1996
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002822
Other Carcinoma, Small Cell Studies:
1. Pilot Study of the Correlation Between the Findings of Atypical/Malignant Cells in Sputum and Fluorescence Bronchoscopy in Patients at Risk for Lung Cancer of the LIFE Imaging System and White Light Bronchoscopy
2. Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer
Related Studies:
Other Carcinoma, Small Cell Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Combination Chemotherapy Followed by Radiation Therapy in Patients With Small Cell Lung Cancer
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