|
Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer Clinical research trials and Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer. Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer clinical trial. Human subjects often get the best healthcare possible for their Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "T" Clinical Trials Conditions > Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer  Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
For Condition: stage 4A pancreatic cancer,duct cell adenocarcinoma of the pancreas,stage 3 pancreatic cancer,acinar cell adenocarcinoma of the pancreas,stage 1 pancreatic cancer,stage 2 pancreatic cancer
Status: Recruiting
Sponsor(s): National Cancer Research Institute (NCRI) , National Cancer Institute of Canada,Australasian Gastro-Intestinal Trials Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective, or whether chemotherapy is more effective than observation, in treating pancreatic cancer after surgery. PURPOSE: Phase III trial to compare the effectiveness of two chemotherapy regimens with no further therapy in treating patients who have completely resected pancreatic cancer.
Details: OBJECTIVES: Primary - Compare the efficacy of adjuvant gemcitabine vs fluorouracil and leucovorin calcium (vs observation only in patients with ampullary or other pancreatic malignancy), in terms of 2-year survival rate, in patients with completely resected pancreatic cancer. Secondary - Compare the toxicity of these regimens in these patients. - Compare the quality of life and 5-year survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to histology (ductal adenocarcinoma vs ampullary or other pancreatic malignancy), resection margin status, and participating country. Patients are randomized to 1 of 2 treatment arms. Randomization for patients with ampullary or other pancreatic malignancy includes an observation arm. - Arm I: Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. - Arm III (patients with ampullary or other pancreatic malignancy only): Patients undergo observation. Treatment in arms I and II repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, 3, 6, and 12 months, and then annually for 5 years. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 660 patients with pancreatic adenocarcinoma (330 per arms I and II) will be accrued for this study within 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed ductal adenocarcinoma of the pancreas OR - Histologically confirmed diagnosis of 1 of the following types of cancer: - Acinar cell carcinoma or cystadenocarcinoma of the pancreas - Cancers of the periampullary region - Cancers of the intrapancreatic part of the bile duct - Periampullary cancers of uncertain origin - Complete macroscopic resection (R0 or R1 resection) - Histological examination of all resection margins required - No stage IVB disease - No evidence of malignant ascites - No liver or peritoneal metastases - No evidence of spread to other distant abdominal or extra-abdominal organs - No pancreatic lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - WHO 0-2 Life expectancy - More than 3 months Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant - Able to participate in long-term follow-up - No other prior or concurrent malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix - No serious medical or psychological condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No neoadjuvant chemotherapy - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics - Recovered from prior resection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnNeoptolemos, Study Chair, University of Liverpool
CancerCare Manitoba *Recruiting*
Winnipeg, Manitoba, R3E 0V9
Canada
Recruiting Ralph Wong 204-235-3044
Uppsala University Hospital *Recruiting*
Uppsala, , S-75185
Sweden
Recruiting Bengt Glimelius 46-18-611-5513
Agia Olga Hospital *Recruiting*
Athens, , G-15233
Greece
Recruiting Christos Dervenis 30-10-277-5467
Policlinico Borgo Roma *Recruiting*
Verona, , 37134
Italy
Recruiting Claudio Bassi 39-045-807-4553
Nova Scotia Cancer Centre *Recruiting*
Halifax, Nova Scotia, B3H 1V7
Canada
Recruiting Daniel Rayson 902-473-6002
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Malcolm Moore 416-946-2263
University of Bern *Recruiting*
Bern, , CH-3012
Switzerland
Recruiting Daniel Candinas 41-31-632-2412
Toronto General Hospital *Recruiting*
Toronto, Ontario, M5G 2C4
Canada
Recruiting Malcolm Moore 416-946-2263
Flinder Medical Centres *Recruiting*
Bedford Park, South Australia, 5042
Australia
Recruiting R. Padbury 61-8-8204-4523
McGill University *Recruiting*
Montreal, Quebec, H2W 1S6
Canada
Recruiting Wilson Miller 514-340-8222 ext. 4365
Hopital Charles Lemoyne *Recruiting*
Greenfield Park, Quebec, J4V 2H1
Canada
Recruiting Eric Bergeron 450-466-5000
Universitaets-Kinderklinik Heidelberg *Recruiting*
Heidelberg, , D-69120
Germany
Recruiting Markus Buchler 49-6221-56-6205
Tampere University Hospital *Recruiting*
Tampere, , 33521
Finland
Recruiting Isto Nordback 358-3-247-4608
St. Joseph's Health Centre - Toronto *Recruiting*
Toronto, Ontario, M6R 1B5
Canada
Recruiting John Blondal 416-530-6586
University of Liverpool *Recruiting*
Liverpool, England, L69 3GA
United Kingdom
Recruiting John Neoptolemos 44-151-706-4175
Institute for Clinical and Experimental Medicine *Recruiting*
Preha 4, , 14021
Czech Republic
Recruiting Miroslav Ryska 420-2-6136-4105
British Columbia Cancer Agency - Vancouver Island Cancer Centre *Recruiting*
Victoria, British Columbia, V8R 6V5
Canada
Recruiting Brian Weinerman 250-519-5501
Institute of Oncology at Prince of Wales Hospital *Recruiting*
Randwick, New South Wales, 2031
Australia
Recruiting David Goldstein 61-2-9382-2577
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Scott Berry 416-480-5248
Hopital Tenon *Recruiting*
Paris, , 75970
France
Recruiting Francois Lacaine 33-1-5601-7000
Ottawa Regional Cancer Centre *Recruiting*
Ottawa, Ontario, K1H 1C4
Canada
Recruiting Derek Jonker 613-737-7700 ext. 6029
Kingston Regional Cancer Centre *Recruiting*
Kingston, Ontario, K7L 5P9
Canada
Recruiting Wycliffe Lofters 613-544-2630 ext. 4502
Mav Hospital *Recruiting*
Budapest, , 1062
Hungary
Recruiting Akos Pap 36-1-302-0841
Cross Cancer Institute *Recruiting*
Edmonton, Alberta, T6G 1Z2
Canada
Recruiting Heather-Jane Au 780-432-8762
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Ian Kerr 519-685-4006
Additional Information:
Study ID Numbers: CDR0000287023; CAN-NCIC-PA2,NCRI-ESPAC-3,EU-20043,AGITG-ESPAC-3
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058201
Other Stage 1 Pancreatic Cancer Studies:
1. Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
2. Cisplatin, Metronomic Low-Dose Interferon alfa, Gemcitabine, and Fever-Range Whole-Body Hyperthermia in Treating Patients With Inoperable or Metastatic Pancreatic Cancer
3. Perifosine in Treating Patients With Advanced Pancreatic Cancer
4. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
5. R115777 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Related Studies:
Other stage 1 pancreatic cancer Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
|
|
|
|
|
|
|
|
