Phase2 trial of oxaliplatin, irinotecan and S-1 (OX-IRIS) as first line chemotherapy for unresectable pancreatic cancer

Conditions

pancreatic cancer

Kazuaki Harada, Shintaro Nakano, Yasuyuki Kawamoto, Kentaro Sawada, Takuto Miyagishima et al. (14 authors)

Journal of Clinical Oncology2024-01-20

10.1200/jco.2024.42.3_suppl.647

Study protocol of the HGCSG1803: a phase II multicentre, non-randomised, single-arm, prospective trial of combination chemotherapy with oxaliplatin, irinotecan and S-1 (OX-IRIS) as first-line treatment for metastatic or relapsed pancreatic cancer

Shintaro Nakano, Yasuyuki Kawamoto, Satoshi Yuki, Kazuaki Harada, Takuto Miyagishima et al. (22 authors)

BMJ Open2022-05-011 citations

10.1136/bmjopen-2021-048833

HGCSG 1803: Single-arm phase II study evaluating efficacy of oxaliplatin, irinotecan and S-1 combination therapy (OX-IRIS) in metastatic pancreatic cancer as first-line treatment.

Shintaro Nakano, Yasuyuki Kawamoto, Satoshi Yuki, Kazuaki Harada, Susumu Sogabe et al. (20 authors)

Journal of Clinical Oncology2020-05-20

10.1200/jco.2020.38.15_suppl.tps4668

Interventions

patients recieve combination chemotherapy (Oxaliplatin+Irinotecan+S-1)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven adenocarcinoma or adenosquamous carcinoma of the advanced or recurrent pancreatic cancer 2. With measurable disease (RECIST v1.1) 3. aged 20 to 75 years old 4. ECOG PS 0 or 1 5. No prior chemotherapy or radiation therapy (in case of previous neoaduvant therapy, interval from operation and relapse must be >6 months, and in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >6 months for S-1 therapy) 6. Expected life span >= 8 weeks 7. Ingestible 8. Hematological status: neutrophils(ANC)>=1.5x109/L; platelets >=100x109/L; haemoglobin >=9g/dL, Adequate renal function: serum creatinine level >=1.2mg/dl, Ccr >=60mL/min, Adequate liver function: serum bilirubin <=2.0 x upper normal limit(ULN), AST/ALT< 2.5 x the ULN for the reference lab 9.Signed and dated informed consent

Exclusion criteria

Exclusion criteria: 1. Active double cancer 2. UGT1A1 double hetero(UGT1A1*6/*28) or homo(UGT1A1*6 or UGT1A1*28) 3. Neuropathy with symptoms 4. blood transfusions within 7 days from registration 5. severe pleural effusion or ascites 6. Watery diarrhea 7. Severe complication 8. Infectious disease 9. Active viral hepatitis 10. Brain metastasis with clinical symptoms 11. systemic steroid use 12. Persons to be pregnant or to make pregnant 13. Contraindication to oxaliplatin, Irinotecan, and S-1 14. Participation in the clinical trial is determined as unsuitable.

Design outcomes

Primary

Measure	Time frame
response rate	—

Secondary

Measure	Time frame
progression free survival overall survival safety dose intensity	—

Contacts

Public ContactYasuyuki Kawamoto

Hokkaido university hospital

y-kawamoto@pop.med.hokudai.ac.jp+81-11-706-5657

Outcome results

None listed