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Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer Clinical research trials and Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer healthcare trials occur in a lot of 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 generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer. Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health 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 and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer  Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
For Condition: Esophageal Cancer,Gastric Cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology 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 before and after surgery may kill more tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of combining radiation therapy with two different chemotherapy regimens before and after surgery in treating patients who have esophageal cancer.
Details: OBJECTIVES: - Compare the pathologic complete response rate in patients with adenocarcinoma of the esophagus or gastroesophageal junction treated with radiotherapy with pre- and post-operative cisplatin plus paclitaxel versus cisplatin plus irinotecan. - Compare the survival outcome in patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the tolerability of these adjuvant chemotherapy regimens after neoadjuvant chemoradiotherapy in these patients. - Compare time to progression or recurrence in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and stage of disease (T2-3, N0, M0 vs T1-3, N0-1, M0 or M1A). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive neoadjuvant radiotherapy once daily, 5 days a week, for 5 weeks beginning on day 1 concurrently with neoadjuvant chemotherapy comprising cisplatin IV over 2-3 hours followed by irinotecan IV over 30-60 minutes once daily on days 1, 8, 22, and 29. Four to six weeks after completion of neoadjuvant chemoradiotherapy, patients undergo surgical resection. A minimum of 4 weeks after resection, patients receive adjuvant chemotherapy comprising cisplatin and irinotecan as above on days 1 and 8. Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses. - Arm II: Patients receive neoadjuvant radiotherapy as in arm I concurrently with neoadjuvant chemotherapy comprising paclitaxel IV over 1 hour followed by cisplatin IV over 2-3 hours once daily on days 1, 8, 15, 22, and 29. Patients then undergo surgical resection as in arm I. A minimum of 4 weeks after resection, patients receive adjuvant chemotherapy comprising paclitaxel IV over 3 hours followed by cisplatin as above on day 1. Treatment with adjuvant chemotherapy repeats every 3 weeks for 3 courses. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years. PROJECTED ACCRUAL: A total of 46-94 patients (23-47 per treatment arm) will be accrued for this study within 1.5-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Newly diagnosed adenocarcinoma of the esophagus (20 cm below incisors) or gastroesophageal junction - Stage T2-3, N0, M0 OR - Stage T1-3, N0-1, M0 or M1A (celiac nodal metastasis) - Tumor must not extend more than 2 cm into the cardia - Tumor must be considered surgically resectable (T1-3, but not T4) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL Renal: - Creatinine clearance at least 60 mL/min Other: - No other concurrent illness that would preclude study therapy or surgical resection - Prior curatively treated malignancy allowed if currently disease-free and survival prognosis is more than 5 years - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent filgrastim (G-CSF) during study radiotherapy Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics - No prior surgery Other: - Endoscopy with biopsy and dilation allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LarryKleinberg, Study Chair, Sidney Kimmel Cancer Center
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Arlene Forastiere 410-955-9818
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Colorado Cancer Research Program, Incorporated *Recruiting*
Denver, Colorado, 80224
United States
Recruiting Eduardo Pajon 303-777-2663
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Additional Information:
Study ID Numbers: CDR0000069309; ECOG-1201
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033657
Other Gastric Cancer Studies:
1. Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction
2. Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
3. Irinotecan and Capecitabine in Treating Patients With Solid Tumors
4. LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
5. Interleukin-12 in Treating Patients With Cancer in the Abdomen
Related Studies:
Other Gastric Cancer Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
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