Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000361606
Ethics application status
Approved
Date submitted
9/09/2005
Date registered
9/09/2005
Date last updated
27/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Adjuvant Chemotherapies in Resectable Pancreatic Cancer
Scientific title
Adjuvant Chemotherapies in Resectable Pancreatic Cancer
Secondary ID [1] 153 0
ESPAC-3
Secondary ID [2] 154 0
National Clinical Trials Registry: NCTR405
Universal Trial Number (UTN)
Trial acronym
ESPAC-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Histologically proven ductal or ampullary cancer of the pancreas having undergone 'curative' resection 456 0
Condition category
Condition code
Cancer 532 532 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gemcitabine vs 5-FU/leucovorin
Intervention code [1] 426 0
Treatment: Drugs
Comparator / control treatment
Observation
Control group
Historical

Outcomes
Primary outcome [1] 613 0
2 year survival
Timepoint [1] 613 0
At 2 years.
Secondary outcome [1] 1279 0
Toxicity
Timepoint [1] 1279 0
Baseline, weekly during treatment then 3 monthly for 5 years
Secondary outcome [2] 1280 0
Quality of Life
Timepoint [2] 1280 0
Baseline, 3, 6, 9, 12 months and annually thereafter for 5 years
Secondary outcome [3] 1281 0
5-year survival
Timepoint [3] 1281 0
5 years post study entry

Eligibility
Key inclusion criteria
* Patients who have undergone complete macroscopic resection for ductal adenocarcinoma of the pancreas (R0 or R1 resection) or patients with other cancers may be included who have had complete macroscopic resection (R0 or R1 resection) for (i) unusual malignancies of the pancreas, such as acinar cell carcinoma, cystadenocarcinoma etc.; (ii) cancers of the periampullary region; (iii) cancers of the intra-pancreatic part of the bile duct; (iv) periampullary cancers of uncertain origin. Patients with tumours as in 1(b) will be analysed separately and will be in addition to the recruitment of pancreatic cancer patients.* Histological confirmation of the primary diagnosis.* Histological examination of all resection margins.* No evidence of malignant ascites, liver metastasis, spread to other distant abdominal organs, peritoneal metastasis, spread to extra-abdominal organs.* WHO performance status < 2* Fully recovered from the operation and fit to take part in the trial. Life-expectancy of more than 3 months.* Able to attend for administration of the adjuvant therapy.* Able to attend for long-term follow-up.* No previous or concurrent malignancy diagnoses (except curatively-treated basal cell carcinoma of skin, carcinoma in situ of cervix).* No serious medical or psychological condition precluding adjuvant treatment.* Fully informed written consent given.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of neo-adjuvant chemotherapy or other concomitant chemotherapy.
* Patients with pancreatic lymphoma.
* Macroscopically remaining tumour (R2 resection)
* Patients with TNM Stage IVb disease.
* Patients younger than 18 years.
* Pregnancy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open Randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software with blocking as stratification
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/10/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1090
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,ACT,QLD,SA,WA,TAS
Recruitment outside Australia
Country [1] 191 0
New Zealand
State/province [1] 191 0
North Island
Country [2] 192 0
New Zealand
State/province [2] 192 0
South Island

Funding & Sponsors
Funding source category [1] 591 0
Government body
Name [1] 591 0
NHMRC Project Grant
Country [1] 591 0
Australia
Funding source category [2] 285310 0
Charities/Societies/Foundations
Name [2] 285310 0
Cancer Council Australia
Country [2] 285310 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastro-Intestinal Trials Group (AGITG)
Address
Level 6, Medical Foundation Building The University of Sydney 92-94 Parramatta Road, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 480 0
None
Name [1] 480 0
N/A
Address [1] 480 0
Country [1] 480 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1650 0
Alfred Hospital
Ethics committee address [1] 1650 0
Commercial Road, Melbourne VIC 3004
Ethics committee country [1] 1650 0
Australia
Date submitted for ethics approval [1] 1650 0
Approval date [1] 1650 0
Ethics approval number [1] 1650 0
Ethics committee name [2] 1651 0
Adelaide Cancer Centre
Ethics committee address [2] 1651 0
Suite 10, Level 1, Tennyson Centre
520 South Road, Kurralta Park SA 5037
Ethics committee country [2] 1651 0
Australia
Date submitted for ethics approval [2] 1651 0
Approval date [2] 1651 0
Ethics approval number [2] 1651 0
Ethics committee name [3] 1652 0
Austin Repatriation Medical Centre
Ethics committee address [3] 1652 0
145 Studley Road, Heidelberg VIC 3084
Ethics committee country [3] 1652 0
Australia
Date submitted for ethics approval [3] 1652 0
Approval date [3] 1652 0
Ethics approval number [3] 1652 0
Ethics committee name [4] 1653 0
Bankstown-Lidcombe Hospital
Ethics committee address [4] 1653 0
70 Eldridge Road, Bankstown NSW 2200
Ethics committee country [4] 1653 0
Australia
Date submitted for ethics approval [4] 1653 0
Approval date [4] 1653 0
Ethics approval number [4] 1653 0
Ethics committee name [5] 1654 0
Border Medical Oncology
Ethics committee address [5] 1654 0
Suite 1/69 Nordsvan Drive, Wodonga VIC 3690
Ethics committee country [5] 1654 0
Australia
Date submitted for ethics approval [5] 1654 0
Approval date [5] 1654 0
Ethics approval number [5] 1654 0
Ethics committee name [6] 1655 0
Campbelltown Hospital
Ethics committee address [6] 1655 0
Therry Rd, Campbelltown NSW 2560
Ethics committee country [6] 1655 0
Australia
Date submitted for ethics approval [6] 1655 0
Approval date [6] 1655 0
Ethics approval number [6] 1655 0
Ethics committee name [7] 1656 0
Canberra Hospital
Ethics committee address [7] 1656 0
The Canberra Hospital /Yamba Drive, Garran ACT 2605
Ethics committee country [7] 1656 0
Australia
Date submitted for ethics approval [7] 1656 0
Approval date [7] 1656 0
Ethics approval number [7] 1656 0
Ethics committee name [8] 1657 0
Christchurch Hospital
Ethics committee address [8] 1657 0
Riccarton Avenue, Christchurch 8011
Ethics committee country [8] 1657 0
New Zealand
Date submitted for ethics approval [8] 1657 0
Approval date [8] 1657 0
Ethics approval number [8] 1657 0
Ethics committee name [9] 1658 0
Flinders Medical Centre
Ethics committee address [9] 1658 0
Flinders Drive, Bedford Park SA 5042
Ethics committee country [9] 1658 0
Australia
Date submitted for ethics approval [9] 1658 0
Approval date [9] 1658 0
Ethics approval number [9] 1658 0
Ethics committee name [10] 1659 0
Frankston Hospital
Ethics committee address [10] 1659 0
Hastings Road, Frankston VIC 3199
Ethics committee country [10] 1659 0
Australia
Date submitted for ethics approval [10] 1659 0
Approval date [10] 1659 0
Ethics approval number [10] 1659 0
Ethics committee name [11] 1660 0
Launceston General Hospital
Ethics committee address [11] 1660 0
274-280 Charles Street, Launceston TAS 7250
Ethics committee country [11] 1660 0
Australia
Date submitted for ethics approval [11] 1660 0
Approval date [11] 1660 0
Ethics approval number [11] 1660 0
Ethics committee name [12] 1661 0
Lismore Hospital
Ethics committee address [12] 1661 0
60 Uralba Street Lismore NSW 2480
Ethics committee country [12] 1661 0
Australia
Date submitted for ethics approval [12] 1661 0
Approval date [12] 1661 0
Ethics approval number [12] 1661 0
Ethics committee name [13] 1662 0
Liverpool Hospital
Ethics committee address [13] 1662 0
Elizabeth St, Liverpool NSW 2170
Ethics committee country [13] 1662 0
Australia
Date submitted for ethics approval [13] 1662 0
Approval date [13] 1662 0
Ethics approval number [13] 1662 0
Ethics committee name [14] 1663 0
Monash Medical Centre
Ethics committee address [14] 1663 0
246 Clayton Road, Clayton VIC
Ethics committee country [14] 1663 0
Australia
Date submitted for ethics approval [14] 1663 0
Approval date [14] 1663 0
Ethics approval number [14] 1663 0
Ethics committee name [15] 1664 0
Nepean Hospital
Ethics committee address [15] 1664 0
Derby St, Kingswood NSW 2747
Ethics committee country [15] 1664 0
Australia
Date submitted for ethics approval [15] 1664 0
Approval date [15] 1664 0
Ethics approval number [15] 1664 0
Ethics committee name [16] 1665 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [16] 1665 0
Edith Street, Waratah NSW 2300
Ethics committee country [16] 1665 0
Australia
Date submitted for ethics approval [16] 1665 0
Approval date [16] 1665 0
Ethics approval number [16] 1665 0
Ethics committee name [17] 1666 0
Prince of Wales Hospital
Ethics committee address [17] 1666 0
Barker Street, Randwick NSW 2031
Ethics committee country [17] 1666 0
Australia
Date submitted for ethics approval [17] 1666 0
Approval date [17] 1666 0
Ethics approval number [17] 1666 0
Ethics committee name [18] 1667 0
Queen Elizabeth Hospital
Ethics committee address [18] 1667 0
28 Woodville Road, Woodville South SA 5011
Ethics committee country [18] 1667 0
Australia
Date submitted for ethics approval [18] 1667 0
Approval date [18] 1667 0
Ethics approval number [18] 1667 0
Ethics committee name [19] 1668 0
Royal Adelaide Hospital
Ethics committee address [19] 1668 0
North Terrace, Adelaide SA 5000
Ethics committee country [19] 1668 0
Australia
Date submitted for ethics approval [19] 1668 0
Approval date [19] 1668 0
Ethics approval number [19] 1668 0
Ethics committee name [20] 1669 0
Royal Hobart Hospital
Ethics committee address [20] 1669 0
48 Liverpool Street, Hobart TAS 7000
Ethics committee country [20] 1669 0
Australia
Date submitted for ethics approval [20] 1669 0
Approval date [20] 1669 0
Ethics approval number [20] 1669 0
Ethics committee name [21] 1670 0
Royal North Shore Hospital
Ethics committee address [21] 1670 0
Reserve Road, St Leonards NSW 2065
Ethics committee country [21] 1670 0
Australia
Date submitted for ethics approval [21] 1670 0
Approval date [21] 1670 0
Ethics approval number [21] 1670 0
Ethics committee name [22] 1671 0
Royal Prince Alfred Hospital
Ethics committee address [22] 1671 0
Sydney Cancer Centre, Missenden Road, Camperdown NSW 2050
Ethics committee country [22] 1671 0
Australia
Date submitted for ethics approval [22] 1671 0
Approval date [22] 1671 0
Ethics approval number [22] 1671 0
Ethics committee name [23] 1672 0
Sir Charles Gairdner Hospital
Ethics committee address [23] 1672 0
Hospital Avenue, Nedlands, Perth 6009
Ethics committee country [23] 1672 0
Australia
Date submitted for ethics approval [23] 1672 0
Approval date [23] 1672 0
Ethics approval number [23] 1672 0
Ethics committee name [24] 1673 0
Sydney Haematology and Oncology Clinics
Ethics committee address [24] 1673 0
13/49 Palmerston Road, Hornsby NSW 2077
Ethics committee country [24] 1673 0
Australia
Date submitted for ethics approval [24] 1673 0
Approval date [24] 1673 0
Ethics approval number [24] 1673 0
Ethics committee name [25] 1674 0
St Vincent's Hospital, Melbourne
Ethics committee address [25] 1674 0
41 Victoria Parade, Fitzroy VIC 3065
Ethics committee country [25] 1674 0
Australia
Date submitted for ethics approval [25] 1674 0
Approval date [25] 1674 0
Ethics approval number [25] 1674 0
Ethics committee name [26] 1675 0
St. Andrews Hospital
Ethics committee address [26] 1675 0
280 North Street, Toowoomba QLD 4350
Ethics committee country [26] 1675 0
Australia
Date submitted for ethics approval [26] 1675 0
Approval date [26] 1675 0
Ethics approval number [26] 1675 0
Ethics committee name [27] 1676 0
Tweed Hospital
Ethics committee address [27] 1676 0
Corner Powell Street & Florence Street, Tweed Heads NSW 2485
Ethics committee country [27] 1676 0
Australia
Date submitted for ethics approval [27] 1676 0
Approval date [27] 1676 0
Ethics approval number [27] 1676 0
Ethics committee name [28] 1677 0
Wellington Hospital
Ethics committee address [28] 1677 0
Riddiford Street, Newtown Wellington 6021
Ethics committee country [28] 1677 0
New Zealand
Date submitted for ethics approval [28] 1677 0
Approval date [28] 1677 0
Ethics approval number [28] 1677 0
Ethics committee name [29] 1678 0
Wesley Medical Centre
Ethics committee address [29] 1678 0
Ethics committee country [29] 1678 0
Australia
Date submitted for ethics approval [29] 1678 0
Approval date [29] 1678 0
Ethics approval number [29] 1678 0
Ethics committee name [30] 1679 0
Western Hospital
Ethics committee address [30] 1679 0
148 Gordon Street, Footscray VIC 3011
Ethics committee country [30] 1679 0
Australia
Date submitted for ethics approval [30] 1679 0
Approval date [30] 1679 0
Ethics approval number [30] 1679 0
Ethics committee name [31] 1680 0
Westmead Hospital
Ethics committee address [31] 1680 0
Corner of Hawkesbury Road and Darcy Road, Westmead NSW 2145
Ethics committee country [31] 1680 0
Australia
Date submitted for ethics approval [31] 1680 0
Approval date [31] 1680 0
Ethics approval number [31] 1680 0
Ethics committee name [32] 287327 0
University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [32] 287327 0
USYD HREC - Office of Research Integrity
Level 6, Jane Foss Russell Building G02
University of Sydney NSW 2006
Ethics committee country [32] 287327 0
Australia
Date submitted for ethics approval [32] 287327 0
Approval date [32] 287327 0
19/02/2002
Ethics approval number [32] 287327 0
02-2002/2661

Summary
Brief summary
Over 1,650 Australians are diagnosed with pancreatic cancer each year. In most cases, surgery will remove the tumour but it is possible that the cancer will return as a result of undetectable disease (micrometastases). The cancer will return and be incurable in the majority of patients, more than 1600 Australians die of the disease every year.

This study compares the impact of adding chemotherapy to the surgery alone (the current standard of care). The study will also compare the effectiveness of two different types of chemotherapy.

Surgical resection of a pancreas tumour is the current standard of care for this disease. It is possible that people treated with chemotherapy after their tumour has been surgically removed may live longer before their disease returns and may liver longer overall. This has been shown to be true in other in cancers; eg. breast and bowel. The side effects of chemotherapy are important and can be severe in some people. Recent studies in advanced pancreatic cancer have suggested that the new drug gemcitabine may be more effective than other drugs. For this reason, the trial compares the outcomes in people treated with gemcitabine to those treated with an older drug 5FU, which has been shown to improve survival in an earlier study by the European group.

This trial will determine if chemotherapy in addition to surgery increases disease-free and overall survival. If it does, it should become standard practice. This study is an important international initiative that will provide unique information about effectiveness of these treatments and their impact on quality of life from the patient's perspective. This study and the previous European study are the largest of their type ever done. 900 people will take part. This study is being conducted in Australia by the Australasian Gastro-Intestinal Trials in collaboration with the Australian Hepatobilary Association and the NHMRC Clinical Trials Centre.
Trial website
http://www.gicancer.org.au/; http://www.ctc.usyd.edu.au/
Trial related presentations / publications
Conference Paper: Continuation of an adjuvant therapy trial in the light of new evidence: Revised design of the European Study Group for Pancreatic Cancer 3 trial (ESPAC-3) (2003). Clinical Oncological Society of Australia (COSA) Annual Scientific Meeting
Authors: Padbury, R;Goldstein, D;Knight, E;Dhillon, H;Tebbutt, N;Yip, S;Simes, J

Journal Article: Adjuvant 5-fluorouracil and folinic acid vs observation for pancreatic cancer: composite data from the ESPAC-1 and -3(v1) trials. (2009), 100(2): 246-250 , BRIT J CANCER.
Authors: Neoptolemos, J P;Stocken, DD;Tudur Smith, C;Bassi, C;Ghaneh, P;Owen, E;Moore, M;Padbury, R;Doi, R;Smith, D;Buchler, MW

Conference Paper: ESPAC-3(v2): a multicentre, international, open label, randomised controlled phase III trial of adjuvant 5-fluorouracil/folinic acid versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma. (2009), 27(18S): Abs#LBA4505, American Society of Clinical Oncology Annual Meeting, J CLIN ONCOL.
Authors: Neoptolemos, J;Büchler, M;Stocken, DD;Ghaneh, P;Smith, D;Bassi, C;Moore, M;Cunningham, D;Dervenis, C;Goldstein, D

Journal Article: Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. (2010), 304(10): 1073–1081, JAMA.
Authors: 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;Cancer, for the European Study Group for Pancreatic Cancer.

Conference Paper: Ampullary cancer ESPAC-3 (v2) trial: A multicenter, international, open-label, randomized controlled phase III trial of adjuvant chemotherapy versus observation in patients with adenocarcinoma of the ampulla of Vater.(2011), 29(S): Abs#LBA4006, American Society of Clinical Oncology Annual Meeting, J CLIN ONCOL.
Authors: Neoptolemos, JP;Moore, MJ;Cox, TF;Valle, JW;Palmer, DH;McDonald, A;Carter, R;Tebbutt, NC;Dervenis, C;Smith, D;Glimelius, B;Coxon, FY;Lacaine, F;Middleton, R;Ghaneh, P;Bassi, C;Halloran, C;Olah, A;Rawcliffe, CL;Büchler, MW;Cancer, European Study Group for Pancreatic Cancer.
Public notes

Contacts
Principal investigator
Name 35167 0
Address 35167 0
Country 35167 0
Phone 35167 0
Fax 35167 0
Email 35167 0
Contact person for public queries
Name 9615 0
ESPAC-3 Trial Coordinator
Address 9615 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 9615 0
Australia
Phone 9615 0
+61 2 9562 5000
Fax 9615 0
+61 2 9562 5094
Email 9615 0
[email protected]
Contact person for scientific queries
Name 543 0
ESPAC-3 Trial Coordinator
Address 543 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
Country 543 0
Australia
Phone 543 0
+61 2 9562 5000
Fax 543 0
+61 2 9562 5094
Email 543 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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