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| ID | Type | Description | Link |
|---|---|---|---|
| RLUH-NCRI-ESPAC-3V2 | |||
| EU-20043 | |||
| CAN-NCIC-PA2 | |||
| AGITG-ESPAC-3 |
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| Name | Class |
|---|---|
| NCIC Clinical Trials Group | NETWORK |
| Australasian Gastro-Intestinal Trials Group | NETWORK |
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.
OBJECTIVES:
Primary
Secondary
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Active Comparator | Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5. |
|
| Arm II | Experimental | Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. |
|
| Arm III | No Intervention | Patients undergo observation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug | Given IV |
| |
| gemcitabine hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
Histologically confirmed ductal adenocarcinoma of the pancreas OR
Histologically confirmed diagnosis of 1 of the following types of cancer:
Complete macroscopic resection (R0 or R1 resection)
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| John P. Neoptolemos, MD | Royal Liverpool University Hospital | Study Chair |
| Malcolm J. Moore, MD | Princess Margaret Hospital, Canada | Study Chair |
| R. Padbury | Flinders Medical Centre | |
| David Goldstein, MD | Institute of Oncology at Prince of Wales Hospital |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology at Prince of Wales Hospital | Randwick | New South Wales | 2031 | Australia | ||
| Flinders Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22782416 | Result | 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. | |
| 20823433 |
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| Drug |
Given IV |
|
| leucovorin calcium | Drug | Given IV |
|
| clinical observation | Other | No intervention |
|
| Bedford Park |
| South Australia |
| 5042 |
| Australia |
| Cross Cancer Institute at University of Alberta | Edmonton | Alberta | T6G 1Z2 | Canada |
| British Columbia Cancer Agency - Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada |
| British Columbia Cancer Agency - Vancouver Island Centre | Victoria | British Columbia | V8R 6V5 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Nova Scotia Cancer Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Cancer Research Institute at Queen's University | Kingston | Ontario | K7L 3N6 | Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| London Regional Cancer Program at London Health Sciences Centre | London | Ontario | N6A 4L6 | Canada |
| Ottawa Hospital Regional Cancer Centre - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Edmond Odette Cancer Centre at Sunnybrook | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| St. Joseph's Health Centre - Toronto | Toronto | Ontario | M6R 1B5 | Canada |
| Hopital Charles Lemoyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| McGill Cancer Centre at McGill University | Montreal | Quebec | H2W 1S6 | Canada |
| Institute for Clinical and Experimental Medicine | Preha 4 | 14021 | Czechia |
| Tampere University Hospital | Tampere | 33521 | Finland |
| Hopital Tenon | Paris | 75970 | France |
| Universitaets-Kinderklinik Heidelberg | Heidelberg | D-69120 | Germany |
| Agia Olga Hospital | Athens | G-15233 | Greece |
| Petz Aladar County Hospital | Gydr | h-9024 | Hungary |
| Policlinico Borgo Roma | Verona | 37134 | Italy |
| Kyoto University Hospital | Kyoto | Kyoto | 606-8507 | Japan |
| Uppsala University Hospital | Uppsala | S-75185 | Sweden |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Royal Liverpool University Hospital | Liverpool | England | L69 3GA | United Kingdom |
| Result |
| 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. |
| 31483448 | Derived | 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. |
| 29068800 | Derived | 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. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000093542 | Gemcitabine |
| D002955 | Leucovorin |
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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