Induction modified FOLFIRINOX for locally advanced pancreatic cancer

JRCT ID: jRCTs051210101

Registered date:06/10/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 05/11/2021
• Target sample size: 29
• Study type: Interventional
• Intervention(s): Interventional treatment of induction modified FOLFIRINOX followed by chemoradiation therapy with S-1 for borderline resectable and unresectable locally advanced pancreatic cancer

Outcome(s)

• Primary Outcome: Overall Response Rate
• Secondary Outcome: Overall survival in each of BR and URLA, two-year survival rate, disease control rate, proportion of patients who received chemoradiotherapy, distant metastasis-free survival, conversion surgery rate, R0 resection rate in patients who performed pancreatomy, adverse event rate, dose intensity, treatment related motality rate/early mortality rate/incidence of severe adverse events(>Gr 3), surgery related motality rate in patients with performed pancreatomy, response evaluation in patients following additional CRT, contents of treatment after protcol treatment

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 75age old
• Gender: Both

Include criteria

1) Pathologically-proven adenocarcinoma by diagnostic imaging
2) Without distant metastasis by chest and abdominal/pelvic MDCT
3) Diagnosed as borderline resectable or unresectable locally advanced pancreatic cancer according to international consensus 2017 of International Association of Pancreatology
4) Without ascites/pleural effusion by chest and abdominal/pelvic CT
5) Without severe gastrointestinal ulcer
6) Age from 20 to 75 years old
7) ECOG performance status of 0 or 1
8) Estimated survival more than three months
9) No prior chemotherapy, radiation therapy or surgical treatment for pancreatic cancer
10) Without interstitial pneumonia on chest CT
11) No watery stool
12) Without peripheral sensory or motor neuropathy (Gr > 1)
13) Adequate function of major organs
14) Written informed consent

Exclude criteria

1) Patients who prefer standard schedule FOFIRINOX or other chemotherapies including GnP if applicable
2) UGT genetic polymorphisms of homozygous UGT1A1*28 or UGT1A1*6 or heterozygous UGT1A1*6 and UGT1A1*28
3) Severe comorbidities [such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes(HbA1c>=10%)]
4) History of unstable ang ina pectoris or myocardial infarction within 6 months before registration.
5) Synchronous or metachronous malignancies except for early cancer
6) Infectious diseases (such as HIV, active tuberculosis, or bacterial infection) requiring systemic treatment, except for viral hepatitis and old pulmonary tuberculosis
7) Severe psychological disorder
8) Continuous systemic medication of corticosteroid or immunosuppressant
9) Pulmonary fibrosis or interstitial pneumonia
10) The history of adverse reactions to both of iodinated contrast media and gadolinium contrast media
11) Patients who are judged to be ineligible by investigators

Related Information

• Primary Sponsor: Ikezawa Kenji
• Secondary Sponsor: Ohkawa Kazuyoshi,Takada Ryoji