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Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic 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 Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer Clinical research trials and Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic 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 Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer. Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic 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 Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic 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 > "G" Clinical Trials Conditions > Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer  Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer
Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer
For Condition: adenocarcinoma of the pancreas,stage 3 pancreatic cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI),Radiation Therapy Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy work in 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. It is not yet known whether gemcitabine is more effective with or without radiation therapy in treating pancreatic cancer. PURPOSE: Randomizedphase III trial to study the effectiveness of gemcitabine with or without radiation therapy in treating patients who have locally advanced, unresectable pancreatic cancer.
Details: OBJECTIVES: - Compare the progression-free and overall survival of patients with locally advanced, unresectable pancreatic cancer treated with gemcitabine with or without radiotherapy. - Compare the objective response rate in patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the quality of life (QOL) of patients treated with these regimens. - Determine the effect of gemcitabine and radiotherapy on the QOL of patients with improved objective response rate and progression-free and overall survival. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1) and weight loss within the past 6 months (less than 10% vs 10% or more). Patients are randomized to 1 of 2 treatment arms. Arm I (Gemcitabine alone): - Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks followed by 1 week of rest. - Consolidation: After the 1 week of rest, patients receive gemcitabine IV once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Arm II (Gemcitabine with radiotherapy): - Induction: Patients receive gemcitabine IV over 30-60 minutes once weekly for 6 weeks beginning on day 1. Patients also undergo concurrent radiotherapy 5 days a week for 5.5 weeks beginning on day 1. - Consolidation: Approximately 4 weeks after completion of radiotherapy, patients receive gemcitabine IV over 30-60 minutes once weekly for 3 weeks. Treatment repeats every 4 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, week 6, week 15 (for arm II), week 16 (for arm I), and 9 months. Patients are followed every 3 months for 2 years and then every 6 months for 1 year. Patients who receive treatment beyond 3 years are followed for survival. PROJECTED ACCRUAL: Approximately 332 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed adenocarcinoma of the pancreas - Locally advanced or regional (encompassable within the same radiotherapy portals) disease - No M1 disease - Adenosquamous cancers are allowed - The following cellular types are not allowed: - Small cell - Mucinous cystadenocarcinoma - Islet cell - Papillary cystic neoplasms - Unresectable disease, defined as a tumor causing superior mesenteric vein or portal vein occlusion OR superior mesenteric artery or hepatic artery encasement - Must not be a candidate for surgical excision based on local extent of disease (e.g., T3, N1, M0) - Measurable and/or nonmeasurable disease by CT scan or MRI PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - At least 12 weeks Hematopoietic - Absolute granulocyte count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin less than 3 mg/dL (unless secondary to biliary obstruction or cholangitis) - AST less than 5 times upper limit of normal (ULN) - Albumin greater than 2.5 g/dL Renal - Creatinine no greater than 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Willing and able to attend follow-up visits - No active infection within the past 4 weeks - No other malignancy within the past 5 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or organ-confined prostate cancer (Gleason score no greater than 7) - No history of active collagen vascular disease (i.e., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma) - No signs or symptoms of peptic or duodenal ulcer disease - No concurrent serious systemic disorders that are incompatible with study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for pancreatic cancer Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy - No concurrent intensity modulated radiotherapy Surgery - See Disease Characteristics Other - More than 4 weeks since prior investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PatrickLoehrer, Study Chair, Indiana University Cancer Center
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Higinia Cardenes 317-274-2524
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
CCOP - Toledo Community Hospital *Recruiting*
Toledo, Ohio, 43623-3456
United States
Recruiting Paul Schaefer 419-843-6147
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Christopher Crane 713-792-6161
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting William Wood 404-778-5180
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
Veterans Affairs Medical Center - East Orange *Recruiting*
East Orange, New Jersey, 07019
United States
Recruiting Basil Kasimis 973-676-1000 ext. 1544
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Daniel Laheru 410-955-8974
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
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
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Additional Information:
Study ID Numbers: CDR0000278947; RTOG-ECOG-4201,ECOG-4201
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057876
Other Adenocarcinoma Of The Pancreas Studies:
1. Gemcitabine and ISIS 2503 in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
2. Perifosine in Treating Patients With Locally Advanced, Unresectable, or Metastatic Pancreatic Cancer
3. Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer
4. Electroporation Therapy With Bleomycin in Treating Patients With Pancreatic Cancer
5. Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
Related Studies:
Other adenocarcinoma of the pancreas Clinical Trials
Other Wisconsin Clinical Trials
Other Marshfield Clinical Trials
Gemcitabine With or Without Radiation Therapy in Treating Patients with Pancreatic Cancer
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