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Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach Clinical research trials and Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach. Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach clinical trial. Participants frequently obtain the most expert healthcare available for their Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach  Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach
Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach
For Condition: recurrent pancreatic cancer,stage 4A pancreatic cancer,recurrent gastric cancer,stage 4 gastric cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , North Central Cancer Treatment Group
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. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus chemotherapy in treating patients who have cancer of the pancreas or stomach.
Details: OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and cisplatin that can be administered during a standard course of radiation therapy for patients with unresectable or locally recurrent pancreatic and gastric cancer. II. Describe the tolerance of gemcitabine, cisplatin, and radiation therapy in this patient population. III. Seek preliminary evidence of the therapeutic activity of this regimen in this patient population as measured by survival. PROTOCOL OUTLINE: This is a dose escalation study. Patients undergo radiotherapy to the tumor and lymph nodes, followed by a decrease in radiotherapy to the tumor alone. Radiation therapy is administered for a total of 5.5 weeks. Patients receive intravenous gemcitabine twice weekly on Tuesday and Friday over the first 3 weeks of radiotherapy. Cisplatin is administered intravenously twice weekly following gemcitabine therapy. Three patients are treated at each dose level. Dose escalation does not occur until all patients at a given dose level have completed radiotherapy and returned for a 4 week follow up. The dose limiting toxicity (DLT) is defined as the dose at which at least 2 of 6 patients experience unacceptable toxic effects. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT. Patients exhibiting stable disease remain on therapy until disease progression or intolerable toxic effects. Patients experiencing toxic effects and no disease progression are retreated at a lower dose. Patients are followed every 3 months for the first 2 years then every 6 months for the next year. PROJECTED ACCRUAL: A total of 6-30 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven unresectable (including incomplete resections) or locally recurrent pancreatic or gastric cancer; No evidence of metastases outside of the planned radiation field; No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin --Prior/Concurrent Therapy-- - Biologic therapy: No prior or concurrent biologic therapy - Chemotherapy: No prior or concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy (except focal fields for skin cancer that do not overlap with planned radiotherapy fields) - Surgery: At least 21 days since laparotomy surgery --Patient Characteristics-- - Age: 18 and over - Performance Status: ECOG 0-1 - Life Expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 2,000/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin within normal limits; Alkaline phosphatase no greater than 3.0 times upper limit of normal (ULN); AST no greater than 3.0 times ULN - Renal: Creatinine no greater than 1.3 times ULN - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No significant infection or medical illness; No significant nausea or vomiting; At least 1200 calories per day of oral nutrition
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesMartenson, Study Chair, North Central Cancer Treatment Group
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
CentraCare Clinic
St. Cloud, Minnesota, 56303
United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57709
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57105-1080
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
Medcenter One Health System
Bismark, North Dakota, 58501
United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68131
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, 85259-5404
United States
Siouxland Hematology-Oncology
Sioux City, Iowa, 51101-1733
United States
Altru Health Systems
Grand Forks, North Dakota, 58201
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
Additional Information:
Study ID Numbers: CDR0000065949; NCCTG-964352
Study Start Date: October 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003157
Other Recurrent Gastric Cancer Studies:
1. Perifosine in Treating Patients With Advanced Pancreatic Cancer
2. UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
3. Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
4. CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
5. 3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Related Studies:
Other recurrent gastric cancer Clinical Trials
Other Illinois Clinical Trials
Other Peoria Clinical Trials
Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas or Stomach
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