Pancreatic CancerPhase 3NCT00058201
Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer
A Phase 3 study testing fluorouracil, gemcitabine hydrochloride and leucovorin calcium in people with Pancreatic Cancer, run by Royal Liverpool University Hospital at 27 sites in 13 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- fluorouracil, gemcitabine hydrochloride and leucovorin calcium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,030 participants
- Where
- 27 sitesin 13 countries
- Study dates
- Jul 2001to Sep 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
27 sites in 13 countries.
27 sites in 13 countries
Canada14 sites
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, T6G 1Z2
Hopital Charles Lemoyne
Greenfield Park, Quebec, J4V 2H1
Nova Scotia Cancer Centre
Halifax, Nova Scotia, B3H 1V7
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Cancer Research Institute at Queen's University
Kingston, Ontario, K7L 3N6
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9
London Regional Cancer Program at London Health Sciences Centre
London, Ontario, N6A 4L6
McGill Cancer Centre at McGill University
Montreal, Quebec, H2W 1S6
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, K1H 8L6
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
St. Joseph's Health Centre - Toronto
Toronto, Ontario, M6R 1B5
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, V8R 6V5
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Australia2 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Institute of Oncology at Prince of Wales Hospital
Randwick, New South Wales, 2031
United Kingdom1 site
Royal Liverpool University Hospital
Liverpool, England, L69 3GA
About this study
Official title: European Study Group For Pancreatic Cancer - Trial 3
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.
Read the detailed description
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 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
- Pancreatic Cancer
- Being tested
- fluorouracil, gemcitabine hydrochloride, leucovorin calcium, clinical observation
- Keywords
- acinar cell adenocarcinoma of the pancreas, duct cell adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorouracilDrug
Given IV
Given IV
Given IV
clinical observationOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Active comparator | Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5. Receives: Drug: fluorouracil; Drug: leucovorin calcium |
| Arm II | Experimental | Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Receives: Drug: gemcitabine hydrochloride |
| Arm III | No intervention | Patients undergo observation. Receives: Other: clinical observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Secondary outcomes (3)
Toxicity as measured by NCI CTC v2.0
Quality of life as measured by EORTC QLQ C-30 and ESPAC-QLQ at 3, 6, and 12 months, and then annually for 5 years
Survival rate at 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startJul 2001
- Primary completionApr 2008
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 1,030 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Liverpool University Hospital
- Sponsor type
- Other government
- Collaborators
- NCIC Clinical Trials Group, Australasian Gastro-Intestinal Trials Group
- Investigators
- John P. Neoptolemos, MD, Study chair, Royal Liverpool University HospitalMalcolm J. Moore, MD, Study chair, Princess Margaret Hospital, CanadaR. Padbury, Flinders Medical CentreDavid Goldstein, MD, Institute of Oncology at Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058201
- Sponsor's protocol ID
- CDR0000287023
- Other IDs
- RLUH-NCRI-ESPAC-3V2, EU-20043, CAN-NCIC-PA2, AGITG-ESPAC-3
- Status last verified
- May 2008
- First submitted
- 7 Apr 2003
- Last updated
- 18 Dec 2013
- Results posted
- No
Publications
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.
PubMed 22782416Neoptolemos 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.
PubMed 20823433Jones 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.
PubMed 31483448Ghaneh 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.
PubMed 29068800
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Study Group For Pancreatic Cancer - Trial 3
- ClinicalTrials.gov ID
- NCT00058201
- Acronym / sponsor ID
- CDR0000287023
- Conditions
- Pancreatic Cancer
- Keywords
- acinar cell adenocarcinoma of the pancreas, duct cell adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,030 participants (estimated)
- Lead sponsor
- Royal Liverpool University HospitalOther government
- Collaborators
- NCIC Clinical Trials Group, Australasian Gastro-Intestinal Trials Group
- Study start
- Jul 2001
- Primary completion
- Apr 2008 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Apr 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Active comparator | Drug: fluorouracil, Drug: leucovorin calciumPatients receive leucovorin calcium IV and fluorouracil IV on days 1-5. |
| Arm II | Experimental | Drug: gemcitabine hydrochloridePatients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. |
| Arm III | No intervention | Other: clinical observationPatients undergo observation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorouracilGiven IV | Drug | Arm I |
| gemcitabine hydrochlorideGiven IV | Drug | Arm II |
| leucovorin calciumGiven IV | Drug | Arm I |
| clinical observationNo intervention | Other | Arm III |
Primary outcome
Overall survival
3 secondary outcomes
Toxicity as measured by NCI CTC v2.0
Quality of life as measured by EORTC QLQ C-30 and ESPAC-QLQ at 3, 6, and 12 months, and then annually for 5 years
Survival rate at 2 and 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2013.
- Results publication: PubMed 22782416Neoptolemos 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.
- Results publication: PubMed 20823433Neoptolemos 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.
- Derived from this study: PubMed 31483448Jones 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.
- Derived from this study: PubMed 29068800Ghaneh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P. Neoptolemos, MD study chair
Royal Liverpool University Hospital
Malcolm J. Moore, MD study chair
Princess Margaret Hospital, Canada
R. Padbury
Flinders Medical Centre
27 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluorouracil, gemcitabine hydrochloride and leucovorin calcium in people with Pancreatic Cancer, run by Royal Liverpool University Hospital at 27 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Canada, Australia, Czechia, Finland, France and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00058201, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2013.