Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
NCT ID: NCT00058201
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1030 participants
INTERVENTIONAL
2001-07-31
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 overall survival, 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 1,030 patients with pancreatic adenocarcinoma (515 per arms I and II) will be accrued for this study.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
fluorouracil
Given IV
leucovorin calcium
Given IV
Arm II
Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
gemcitabine hydrochloride
Given IV
Arm III
Patients undergo observation.
clinical observation
No intervention
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
fluorouracil
Given IV
gemcitabine hydrochloride
Given IV
leucovorin calcium
Given IV
clinical observation
No intervention
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
NCIC Clinical Trials Group
NETWORK
Australasian Gastro-Intestinal Trials Group
NETWORK
Royal Liverpool University Hospital
OTHER_GOV
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John P. Neoptolemos, MD
Role: STUDY_CHAIR
Royal Liverpool University Hospital
Malcolm J. Moore, MD
Role: STUDY_CHAIR
Princess Margaret Hospital, Canada
R. Padbury
Role:
Flinders Medical Centre
David Goldstein, MD
Role:
Institute of Oncology at Prince of Wales Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Cancer Research Institute at Queen's University
Kingston, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre - Toronto
Toronto, Ontario, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Institute for Clinical and Experimental Medicine
Preha 4, , Czechia
Tampere University Hospital
Tampere, , Finland
Hopital Tenon
Paris, , France
Universitaets-Kinderklinik Heidelberg
Heidelberg, , Germany
Agia Olga Hospital
Athens, , Greece
Petz Aladar County Hospital
Gydr, , Hungary
Policlinico Borgo Roma
Verona, , Italy
Kyoto University Hospital
Kyoto, Kyoto, Japan
Uppsala University Hospital
Uppsala, , Sweden
Inselspital Bern
Bern, , Switzerland
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Neoptolemos JP, Moore MJ, Cox TF, Valle JW, Palmer DH, McDonald AC, Carter R, Tebbutt NC, Dervenis C, Smith D, Glimelius B, Charnley RM, Lacaine F, Scarfe AG, Middleton MR, Anthoney A, Ghaneh P, Halloran CM, Lerch MM, Olah A, Rawcliffe CL, Verbeke CS, Campbell F, Buchler MW; European Study Group for Pancreatic Cancer. Effect of adjuvant chemotherapy with fluorouracil plus folinic acid or gemcitabine vs observation on survival in patients with resected periampullary adenocarcinoma: the ESPAC-3 periampullary cancer randomized trial. JAMA. 2012 Jul 11;308(2):147-56. doi: 10.1001/jama.2012.7352.
Neoptolemos JP, Stocken DD, Bassi C, Ghaneh P, Cunningham D, Goldstein D, Padbury R, Moore MJ, Gallinger S, Mariette C, Wente MN, Izbicki JR, Friess H, Lerch MM, Dervenis C, Olah A, Butturini G, Doi R, Lind PA, Smith D, Valle JW, Palmer DH, Buckels JA, Thompson J, McKay CJ, Rawcliffe CL, Buchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010 Sep 8;304(10):1073-81. doi: 10.1001/jama.2010.1275.
Jones RP, Psarelli EE, Jackson R, Ghaneh P, Halloran CM, Palmer DH, Campbell F, Valle JW, Faluyi O, O'Reilly DA, Cunningham D, Wadsley J, Darby S, Meyer T, Gillmore R, Anthoney A, Lind P, Glimelius B, Falk S, Izbicki JR, Middleton GW, Cummins S, Ross PJ, Wasan H, McDonald A, Crosby T, Ting Y, Patel K, Sherriff D, Soomal R, Borg D, Sothi S, Hammel P, Lerch MM, Mayerle J, Tjaden C, Strobel O, Hackert T, Buchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial. JAMA Surg. 2019 Nov 1;154(11):1038-1048. doi: 10.1001/jamasurg.2019.3337.
Ghaneh P, Kleeff J, Halloran CM, Raraty M, Jackson R, Melling J, Jones O, Palmer DH, Cox TF, Smith CJ, O'Reilly DA, Izbicki JR, Scarfe AG, Valle JW, McDonald AC, Carter R, Tebbutt NC, Goldstein D, Padbury R, Shannon J, Dervenis C, Glimelius B, Deakin M, Anthoney A, Lerch MM, Mayerle J, Olah A, Rawcliffe CL, Campbell F, Strobel O, Buchler MW, Neoptolemos JP; European Study Group for Pancreatic Cancer. The Impact of Positive Resection Margins on Survival and Recurrence Following Resection and Adjuvant Chemotherapy for Pancreatic Ductal Adenocarcinoma. Ann Surg. 2019 Mar;269(3):520-529. doi: 10.1097/SLA.0000000000002557.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RLUH-NCRI-ESPAC-3V2
Identifier Type: -
Identifier Source: secondary_id
EU-20043
Identifier Type: -
Identifier Source: secondary_id
CAN-NCIC-PA2
Identifier Type: -
Identifier Source: secondary_id
AGITG-ESPAC-3
Identifier Type: -
Identifier Source: secondary_id
CDR0000287023
Identifier Type: -
Identifier Source: org_study_id