JCOG1611: Randomized phase II/III study of gemcitabine plus nab-paclitaxel combination therapy versus modified FOLFIRINOX versus S-IROX for metastatic or recurrent pancreatic cancer

Phase 2

• Conditions: metastatic or recurrent pancreatic cancer

• Registration Number: JPRN-jRCTs031190009
• Lead Sponsor: ENO Makoto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 732

Inclusion Criteria

(1) Histologically or cytologically proven pancreatic carcinoma meeting either one of the following conditions in primary tumor or metastatic lesion.
(i) Histologically proven invasive ductal carcinoma; adenocarcinoma (well differentiated type, moderately differentiated type, or poorly differentiated adenocarcinoma) or adenosquamous carcinoma, and it is radiologically diagnosed to be compatible with invasive ductal carcinoma
(ii) Cytologically proven Class IV or Class V and it is radiologically diagnosed to be compatible with invasive ductal carcinoma
(2) The presence of organ metastasis or recurrent pancreatic cancer by chest computed tomography (CT) and enhanced abdominal/pelvic CT or magnetic resonance imaging (MRI).
(3) The absence of massive ascites by enhanced abdominal/pelvic CT or MRI.
(4) No evidence of central nervous system metastases with symptoms. Brain CT and/or MRI before registration is not required.
(5) Age, 20 - 75 years.
(6) ECOG performance status, 0 or 1.
(7) Phase II: A measurable lesion is required by chest and enhanced abdominal/pelvic CT or MRI. Phase III: A measurable lesion is not required.
(8) No previous chemotherapy or radiotherapy for pancreatic cancer. Patients with recurrent cancer 24 or more weeks after receiving postoperative chemotherapy of S-1 or gemcitabine is eligble. Patients with recurrent cancer 24 or more weeks after receiving preoperative chemotherapy of gemcitabine plus S-1 and postoperative chemotherapy of S-1 or gemcitabine is eligble.
(9) No watery stool.
(10) No grade 2 or greater peripheral sensory neuropathy or peripheral motor neuropathy.
(11) Sufficient oral intake
(12) UGT1A1 genotypes that do not include *6/*6, *28/*28, or *6/*28.
(13) Adequate function of major organs.
(14) Written informed consent.

Exclusion Criteria

(1) Synchronous or metachronous (within 2 years) malignancies.
(2) Infectious disease requiring systemic treatment (excluding hepatitis viral).
(3) Pyrexia of 38 or higher degrees centigrade.
(4) Female during pregnancy, within 28 days of postparturition, or during lactation and male expecting partner's pregnancy.
(5) Severe psychological disorders.
(6) Receiving continuous systemic corticosteroid or immunosuppressants.
(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, ileus, poorly controlled diabetes, or 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) Requiring continuous administration of either one of flucytosine, phenytoin, or warfarin.
(11) Allergy to iodine or gadolinium.

Study & Design

• Study Type: Interventional
• Study Design: Not specified