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Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus Clinical research trials and Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus. Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus clinical trial. Participants frequently get the best healthcare available for their Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus  Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus
Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus
For Condition: radiation toxicity,Drug Toxicity,Gastric Cancer,Esophageal Cancer
Status: Suspended
Sponsor(s): North Central Cancer Treatment Group , National Cancer Institute (NCI)
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 radiation therapy with chemotherapy and giving them before surgery may shrink the tumor so that it can be removed during surgery. Amifostine may protect normal cells from the side effects of radiation therapy and chemotherapy. PURPOSE: Phase II trial to study the effectiveness of radiation therapy, combination chemotherapy, and amifostine followed by surgery to remove the esophagus in treating patients who have locally advanced cancer of the esophagus.
Details: OBJECTIVES: - Determine the tolerability of radiotherapy concurrently with paclitaxel, carboplatin, fluorouracil, and amifostine before esophagectomy in patients with locally advanced cancer of the esophagus or gastroesophageal junction. - Determine the tumor response rate in patients treated with this regimen. - Determine the quality of life of patients treated with this regimen. - Assess the relationship between the presence of genetic polymorphisms in these patients and the toxicity of this regimen. OUTLINE: This is a multicenter study. Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and fluorouracil IV continuously on days 1-42. Beginning on day 1 of chemotherapy, patients receive amifostine subcutaneously followed 15-60 minutes later by radiotherapy to the esophagus 5 days a week for 5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete dissection of the mediastinal and perigastric lymph nodes. Beginning 8 weeks after surgery, patients who underwent curative resection may receive a maximum of 2 additional courses of paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, before chemotherapy on days 1 and 22, and within 2 weeks before surgery. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: A total of 10-55 patients will be accrued for this study within 10 months to 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction - Surgically resectable disease (T1-3; NX, N0, or N1; M1a) - T4 tumors that are not unequivocally unresectable allowed - Celiac lymph node (stations 15-20) involvement allowed - Must be considered a potential surgical candidate by a thoracic or general surgeon - No supraclavicular lymph node involvement by palpation, biopsy, or radiograph (greater than 1.5 cm) - No distant metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 - Patients with ECOG 2 must be considered good candidates for study by treating oncologists Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST no greater than 3 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No New York Heart Association class III or IV heart disease Other - No uncontrolled infection - No other severe underlying disease that would preclude study participation - No grade 2 or greater peripheral neuropathy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for esophageal cancer Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy to anticipated fields of study radiotherapy Surgery - See Disease Characteristics Other - No concurrent hypertensive medication during radiotherapy - No concurrent diuretics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AminahJatoi, Study Chair, Mayo Clinic Cancer Center
Altru Health System
Grand Forks, North Dakota, 58201
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Medical Oncology and Hematology Associates
Des Moines, Iowa, 50309
United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, 20060
United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, 48106
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
MBCCOP - Hawaii
Honolulu, Hawaii, 96813
United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Canada
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
CCOP - Dayton
Dayton, Ohio, 45429
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212-4772
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43623-3456
United States
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
United States
CentraCare Health Plaza
St. Cloud, Minnesota, 56303
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Additional Information:
Study ID Numbers: CDR0000068789; NCCTG-N0044
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022139
Other Drug Toxicity Studies:
1. Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer
2. Interleukin-12 in Treating Patients With Cancer in the Abdomen
3. Biological Therapy in Treating Patients With Metastatic Cancer
4. Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer
5. Interleukin-12 in Treating Patients With Refractory Advanced-Stage Ovarian Cancer or Abdominal Cancer
Related Studies:
Other Drug Toxicity Clinical Trials
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Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus
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