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NCT00058201 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2013-12-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive leucovorin calcium IV and fluorouracil IV on days 1-5.
    intervention Names
    1. Drug: fluorouracil
    2. Drug: leucovorin calcium
    label
    Arm I
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15.
    intervention Names
    1. Drug: gemcitabine hydrochloride
    label
    Arm II
    type
    EXPERIMENTAL
  3. description
    Patients undergo observation.
    intervention Names
    1. Other: clinical observation
    label
    Arm III
    type
    NO_INTERVENTION
interventions
  1. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    fluorouracil
    type
    DRUG
  2. arm Group Labels
    1. Arm II
    description
    Given IV
    name
    gemcitabine hydrochloride
    type
    DRUG
  3. arm Group Labels
    1. Arm I
    description
    Given IV
    name
    leucovorin calcium
    type
    DRUG
  4. arm Group Labels
    1. Arm III
    description
    No intervention
    name
    clinical observation
    type
    OTHER
Study design
allocation
RANDOMIZED
primary Purpose
TREATMENT
Enrollment
count
1030
type
ESTIMATED
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Overall survival
secondary Outcomes
  1. measure
    Toxicity as measured by NCI CTC v2.0
  2. measure
    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
  3. measure
    Survival rate at 2 and 5 years
Full study description
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.
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.
Source references
references
  1. citation
    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
    type
    RESULT
  2. citation
    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
    type
    RESULT
  3. citation
    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
    type
    DERIVED
  4. citation
    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
    type
    DERIVED
Source notices and limitations
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        ients who received gemcitabine alone.</li></ul></div></li><li>Gemcitabine and capecitabine: The European Study for Pancreatic Cancer (<a href="/clinicaltrials/NCT00058201">ESPAC-4</a> [NCT00058201]) trial randomly assigned 732 patients with resected pancreatic cancer to receive either six cycles of gemcitabine alone (1,000 mg/m<
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    Preserved source evidence · Not medical advice