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Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage 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 Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer Clinical research trials and Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage 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 Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer. Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage 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 Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage 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 > "R" Clinical Trials Conditions > Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer  Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer
Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer
For Condition: limited stage small cell lung cancer
Status: No longer recruiting
Sponsor(s): London Lung Cancer Group ,
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 with radiation therapy may kill more tumor cells. The best timing for radiation therapy and combination chemotherapy in treating limited stage small cell lung cancer is not yet known. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy given at different times along with combination chemotherapy in treating patients with limited stage small cell lung cancer.
Details: OBJECTIVES: I. Determine whether long term survival is affected by the timing of thoracic radiotherapy in patients with limited stage small cell lung cancer who are receiving combination chemotherapy. II. Determine whether the development of local recurrence and distant metastases are affected by the timing of thoracic radiotherapy in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center. All patients receive cyclophosphamide, doxorubicin, and vincristine by IV bolus alternating with 3 days of daily etoposide IV infusion over 60-120 minutes and cisplatin IV infusion over 30 minutes. This treatment alternates every 3 weeks for six courses. Patients are randomized to have thoracic radiotherapy either with course 2 (arm I) or with course 6 (arm II) of chemotherapy. Patients in arm I are given 1 week of rest between radiotherapy and the second course of chemotherapy. If there is no disease progression after chemotherapy and locoregional irradiation, and a repeat brain scan is negative, patients receive prophylactic brain irradiation. Patients are followed monthly for the first year and then every 2 months thereafter. PROJECTED ACCRUAL: This study will accrue 398 patients.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /74 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed limited stage small cell lung cancer - Limited disease defined as within the hemithorax, mediastinum, or ipsilateral supraclavicular nodes - No evidence of extensive disease (i.e., contralateral lung or contralateral supraclavicular nodes) - No metastatic disease - Measurable or evaluable disease --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: Concurrent prednisone or other corticosteroids for hypercalcemia allowed - Radiotherapy: No prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: Under 75 - Performance status: ECOG 0-3 - Life expectancy: At least 8 weeks - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2 mg/dL - Renal: Creatinine normal OR Creatinine clearance greater than 50 mL/min OR Pentetic acid/ethylenediaminetetraacetic acid clearance greater than 70 mL/min - Cardiovascular: No myocardial infarction in the 3 months prior to diagnosis; No pericardial effusion - Pulmonary: No pleural effusion seen on chest x-ray; Pleural effusion identified on CT allowed, if not visible on chest x-ray - Other: No medical condition that excludes the use of chemotherapy or thoracic irradiation; Must be able to tolerate the prescribed study radiotherapy; No other malignant tumor for at least 3 years except nonmelanoma skin cancer
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenSpiro, Study Chair, London Lung Cancer Group
Peterborough Hospitals Trust
Peterborough, England, PE3 6DA
United Kingdom
Heatherwood Hospital
Ascot, England, SL5 8AA
United Kingdom
Mount Vernon Hospital
Northwood, England, HA6 2RN
United Kingdom
Middlesex Hospital- Meyerstein Institute
London, England, WIT 3AA
United Kingdom
Essex County Hospital
Colchester, England,
United Kingdom
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
United Kingdom
Broomfield Hospital
Chelmsford, Essex, England, CM1 5ET
United Kingdom
Southend NHS Trust Hospital
Westcliff-On-Sea, England,
United Kingdom
Cookridge Hospital
Leeds, England, LS16 6QB
United Kingdom
Royal Free Hospital
Hampstead, London, England, NW3 2QG
United Kingdom
Saint Bartholomew's Hospital
London, England, EC1A 7BE
United Kingdom
Guy's and St. Thomas' Hospitals Trust
London, England, SE1 9RT
United Kingdom
Charing Cross Hospital
London, England, W6 8RF
United Kingdom
Royal Sussex County Hospital
Brighton, England, BN2 5BE
United Kingdom
Additional Information:
Study ID Numbers: CDR0000066349; LLCG-TR8SCLC,EU-98011
Study Start Date: January 1993
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003364
Other Limited Stage Small Cell Lung Cancer Studies:
1. Combination Chemotherapy, Radiation Therapy, and Vaccine Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
2. Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
3. Vaccine Therapy Plus QS21 in Treating Patients With Small Cell Lung Cancer That Has Responded to Initial Therapy
4. Radiation Therapy in Preventing Brain Metastases in Patients With Small Cell 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 England Clinical Trials
Other Chelmsford, Essex Clinical Trials
Radiation Therapy Plus Combination Chemotherapy In Treating Patients With Limited Stage Small Cell Lung Cancer
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