JCOG1407: Randomized phase II study of modified FOLFIRINOX versus gemcitabine plus nab-paclitaxel combination therapy for locally advanced pancreatic cancer

Phase 2

• Conditions: locally advanced pancreatic cancer

• Registration Number: JPRN-jRCTs031180085
• Lead Sponsor: Furuse Junji

Brief Summary

There was no substantial difference in efficacy and safety between modified FOLFIRINOX and gemcitabine plus nab-paclitaxel for locally advanced pancreatic cancer. The efficacy of both modified FOLFIRINOX and gemcitabine plus nab-paclitaxel is superior to that of gemcitabine alone, suggesting that modified FOLFIRINOX and gemcitabine plus nab-paclitaxel are the standard chemotherapy for locally advanced pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-17
• Study Completion: 2022-01-05
• Results First Posted: 2022-12-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1) Histologically or cytologically proven adenocarcinoma and consistent with papillary adenocarcinoma, tubular adenocarcinoma, poor differentiated adenocarcinoma, or adenosquamous carcinoma by diagnostic imaging
2) Without obvious organ metastasis (M0) by chest CT and enhanced abdominal/pelvic CT
3) Diagnosed as UICC-T4 or UICC-T3 with invasion to common hepatic artery, hepatic artery proper, or portal vein by enhanced abdominal and pelvic CT
4) Without ascites/pleural effusion by chest CT and enhanced abdominal/pelvic CT
5) A measurable lesion is not required
6) Age from 20 to 75 years
7) ECOG performance status of 0 or 1
8) No diarrhea
9) No peripheral sensory neuropathy and peripheral motor neuropathy
10) No prior surgical treatment for pancreatic cancer
11) No previous chemotherapy or radiotherapy for other malignancies
12) UGT1A1 genotype of neither *6/*6, *28/*28, nor *6/*28
13) Adequate function of major organs
14) Written informed consent

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancies.
2) Infectious disease requiring systemic treatment (excluding hepatitis viral).
3) Pyrexia of 38 degrees centigrade or higher.
4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
5) Severe psychological disorder.
6) Receiving continuous systemic corticosteroid or immunosuppressant treatment.
7) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT
8) Severe comorbidities (such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes and poorly controlled hypertension)
9) History of unstable angina pectoris with new onset or exacerbation within recent 3 weeks or myocardial infarction within 6 months before registration.
10) Allergy to iodine and gadolinium

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (proportion of 1-year survival)

Secondary Outcome Measures

Name	Time	Method
Response rate in patients with target lesions, CA19-9 response, distant metastasis-free survival, progression-free survival, adverse events, dose-intensity, treatment-related death, early death, grade 4 non-hematological toxicity