Standard (Gemcitabine) versus Intensive (FOLFOXIRI) chemotherapy as preventing chemotherapy after resection of pancreatic cancer

PHASE III ITALIAN MULTICENTER STUDY COMPARING THE COMBINATION OF 5-FLUOROURACIL/FOLINIC ACID, OXALIPLATIN AND IRINOTECAN (FOLFOXIRI) VERSUS GEMCITABINE AS ADJUVANT TREATMENT FOR RESECTED PANCREATIC CANCER

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003080-59-IT

Enrollment

310

Registered

2013-08-16

Start date

2013-12-19

Completion date

Unknown

Last updated

2014-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage I-III resected pancreatic cancer MedDRA version: 14.1 Level: PT Classification code 10052747 Term: Adenocarcinoma pancreas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: CAMPTO*INFUS 100MG 5ML 20MG/ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: IRINOTECAN CAS Number: 97682-44-5 Concentration unit: mg/m2 milligram(s)/squa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -histological diagnosis of pancreatic cancer -surgical resection with curative intent within 10 weeks before of enrollment (stage I-III) -absence of evidence of metastases (cM0) -age 18-75 -ECOG performance status 0-1 -adequate bone marrow, liver and renal function -written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 210 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: -evidence of metastases -CA19.9 higher than 2.5 x ULN (upper limit of normal range) -precedent chemotherapy or radiotherapy -coexisting malignancies -relevant coexisting diseases that could contraindicate the participation to the study -hypersensitivity/intolerance to the drugs in study -pregnancy or breastfeeding -neurotoxicity of grade > 1 -malabsorption syndrome

Design outcomes

Primary

Measure	Time frame
Main Objective: To show an increase in disease-free survival with an HR of 0.70 for patients enrolled into the experimental arm compared with standard arm.;Secondary Objective: To show an increase in overall survival with an HR of 0.70 for patients enrolled into the experimental arm compared with standard arm. To show the tolerability of the experimental treatment in this setting. ;Primary end point(s): Disease-free survival, defined as the time from enrollment to the evidence of progression of disease or death.;Timepoint(s) of evaluation of this end point: Patients will be followed up during and after treatment for at least 5 years every three months in the first 2 years and every 6 months in the following 3 years.	—

Measure

Time frame

Main Objective: To show an increase in disease-free survival with an HR of 0.70 for patients enrolled into the experimental arm compared with standard arm.;Secondary Objective: To show an increase in overall survival with an HR of 0.70 for patients enrolled into the experimental arm compared with standard arm. To show the tolerability of the experimental treatment in this setting. ;Primary end point(s): Disease-free survival, defined as the time from enrollment to the evidence of progression of disease or death.;Timepoint(s) of evaluation of this end point: Patients will be followed up during and after treatment for at least 5 years every three months in the first 2 years and every 6 months in the following 3 years.

—

Secondary

Measure	Time frame
Secondary end point(s): Overall survival, defined as the time from enrollment to the evidence of death. Toxicity, defined according to NCI-CTC ;Timepoint(s) of evaluation of this end point: Patients will be followed up during and after treatment for at least 5 years every three months in the first 2 years and every 6 months in the following 3 years. Toxicity will be evaluated baseline, at every drug dose administration and after the end of treatment. Residual toxicity will be followed up every three months in the first 2 years after treatment and every 6 months in the following 3 years.	—

Measure

Time frame

Secondary end point(s): Overall survival, defined as the time from enrollment to the evidence of death. Toxicity, defined according to NCI-CTC ;Timepoint(s) of evaluation of this end point: Patients will be followed up during and after treatment for at least 5 years every three months in the first 2 years and every 6 months in the following 3 years. Toxicity will be evaluated baseline, at every drug dose administration and after the end of treatment. Residual toxicity will be followed up every three months in the first 2 years after treatment and every 6 months in the following 3 years.

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Countries

Italy

Contacts

Public ContactUFFICIO SPERIMENTAZIONI CLINICHE

Polo Oncologico AOUP, Ospedale S. Chiara

trials.office.pisa@gmail.com+39050992192

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026