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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 References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about 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 devoted 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 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, 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 permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated 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. Subjects often receive the most expert 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, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern 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 3 Esophageal Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Cancer of the Esophagus
2. Celecoxib, Paclitaxel, and Carboplatin in Treating Patients With Cancer of the Esophagus
3. Surgery With or Without Radiation Therapy and Chemotherapy in Treating Patients With Esophageal Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage II or Stage III Cancer of the Esophagus
5. Surgery With or Without Combination Chemotherapy in Treating Patients With Cancer of the Esophagus
Related Studies:
Other stage 3 esophageal cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore 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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