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Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer Clinical research trials and Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer. Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer  Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
For Condition: squamous cell carcinoma of the esophagus,stage 3 esophageal cancer,Adenocarcinoma of the Esophagus,stage 2 esophageal cancer,stage 1 esophageal cancer
Status: No longer recruiting
Sponsor(s): Washington Hospital Center ,
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. Giving chemotherapy drugs and radiation therapy before surgery may shrink the tumor so that it can be removed during surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy given before surgery in treating patients who have stage I, stage II, or stage III esophageal cancer.
Details: OBJECTIVES: I. Determine the total response rate in patients with stage I, II, or III esophageal cancer treated with paclitaxel, carboplatin, and fluorouracil with concurrent radiotherapy followed by surgical resection. II. Determine the overall survival of these patients treated with this regimen. II. Determine the toxicity of this regimen in this patient population. PROTOCOL OUTLINE: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1 and 22, and fluorouracil IV continuously on days 1-42. Patients undergo radiotherapy concurrently with chemotherapy daily 5 days a week for 5 weeks. Patients then undergo surgical resection within 3-5 weeks following completion of therapy. Patients are followed every 3 months for 6 months, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed squamous cell carcinoma or adenocarcinoma of the upper, middle, or lower third esophagus; Stage I, II, or III disease - Measurable disease - No distant metastases; Negative liver biopsy; Negative bone scan unless due to benign disease - No tracheobronchial involvement - No vocal cord paralysis - No phrenic nerve involvement - No celiac axis lymph node involvement unless due to primary cancer at gastroesophageal junction - No evidence of disseminated cancer --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior chest radiotherapy - Surgery: No prior surgical resection of tumor - Other: No prior therapy for esophageal cancer --Patient Characteristics-- - Age: Not specified - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 10 g/dL - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGOT/SGPT no greater than 2 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2 times ULN - Renal: Creatinine no greater than 1.5 mg/dL; Creatinine clearance at least 60 mL/min - Cardiovascular: No uncontrolled or severe cardiovascular disease; No congestive heart failure; No myocardial infarction within the past 6 months; No severe or uncontrolled hypertension (systolic greater than 150 mmHg and diastolic greater than 100 mmHg) - Pulmonary: FEV1/FVC at least 75% predicted; Arterial blood saturation at least 92% - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other malignancy except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix; No other serious medical illness that would limit survival to fewer than 2 years; No active uncontrolled bacterial, viral, or fungal infection; No active uncontrolled duodenal ulcer; No psychiatric disorder that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidPerry, Study Chair, Washington Hospital Center
Union Memorial Hospital
Baltimore, Maryland, 21218
United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
United States
Harbor Hospital Center
Baltimore, Maryland, 21225
United States
Good Samaritan Hospital of Maryland
Baltimore, Maryland, 21239
United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237
United States
Additional Information:
Study ID Numbers: CDR0000068295; WHC-99692,NCI-V00-1633
Study Start Date: January 2000
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006472
Other Stage 2 Esophageal Cancer Studies:
1. Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
2. Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
3. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
4. PET Scan in Patients With Lung and Esophageal Cancers That May Be Removed by Surgery
5. Vaccine Therapy, Interleukin-2, and Sargramostim in Treating Patients With Advanced Tumors
Related Studies:
Other stage 2 esophageal cancer Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Combination Chemotherapy Plus Radiation Therapy Followed By Surgery in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer
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