Two Chemotherapy Regimens Compared With Observation in Treating Patients With Completely Resected Pancreatic Cancer

NCT00058201 | Completed Phase 3

• 5 other identifiers: CDR0000287023RLUH-NCRI-ESPAC-3V2EU-20043CAN-NCIC-PA2AGITG-ESPAC-3
• Study Type: interventional
• Target: 1,030
• Locations: 13 countries
• Sites: 27

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Arm I

ACTIVE COMPARATOR

Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.

Drug: fluorouracil; Drug: leucovorin calcium

Arm II

EXPERIMENTAL

Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.

Drug: gemcitabine hydrochloride

Arm III

NO INTERVENTION

Patients undergo observation.

Other: clinical observation

Interventions

fluorouracil DRUG

Given IV

Arm I

gemcitabine hydrochloride DRUG

Given IV

Arm II

leucovorin calcium DRUG

Given IV

Arm I

clinical observation OTHER

No intervention

Arm III

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Royal Liverpool University Hospital: lead
• NCIC Clinical Trials Group: collaborator
• Australasian Gastro-Intestinal Trials Group: collaborator

Study Sites (27)

Institute of Oncology at Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

British Columbia Cancer Agency - Vancouver Island Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Cancer Research Institute at Queen's University

Kingston, Ontario, K7L 3N6, Canada

Location

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Kingston, Ontario, K7L 5P9, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Edmond Odette Cancer Centre at Sunnybrook

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

St. Joseph's Health Centre - Toronto

Toronto, Ontario, M6R 1B5, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Institute for Clinical and Experimental Medicine

Preha 4, 14021, Czechia

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Hopital Tenon

Paris, 75970, France

Location

Universitaets-Kinderklinik Heidelberg

Heidelberg, D-69120, Germany

Location

Agia Olga Hospital

Athens, G-15233, Greece

Location

Petz Aladar County Hospital

Gydr, h-9024, Hungary

Location

Policlinico Borgo Roma

Verona, 37134, Italy

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Uppsala University Hospital

Uppsala, S-75185, Sweden

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Royal Liverpool University Hospital

Liverpool, England, L69 3GA, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 22782416 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.

  PMID: 20823433 RESULT

• 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.

  PMID: 31483448 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.

  PMID: 29068800 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Fluorouracil; Gemcitabine; Leucovorin; Watchful Waiting

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: July 1, 2001
• Primary Completion: April 1, 2008
• Study Completion: September 1, 2010
• Last Updated: December 18, 2013

Record last verified: 2008-05

Locations

FR (1); SE (1); CZ (1); JP (1); GB (1); AU (2); HU (1); CH (1); CA (14); FI (1); GR (1); IT (1); DE (1)