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Phase 2 study of S-IROX as down staging chemotherapy for borderline resectable pancreatic cancer (BR-SIROX)

BR-SIROX

23

23 patients were enrolled, of whom 15 were BRA cases. The median age was 68 years, 14 were male, 21 had PS0 and 2 had PS1. Median CA19 9 at enrollment was 89.

The pace of enrollment has been largely as expected compared to the originally planned pace. The study was conducted at a single site at the National Cancer Center Hospital; 24 patients were scheduled to be enrolled over 3 years, with 23 patients enrolled per 3 year period. The expected number of patients to be enrolled was 24. To account for post-enrollment ineligibility, the number of patients was set at 24, and the study was considered complete after 23 patients were enrolled. Of the 23 patients, 19 of 23 completed prior chemotherapy as required by the protocol. The reasons for discontinuation of prior chemotherapy were worsening of the primary disease and adverse events. Compliance with preoperative chemotherapy was relatively good.

Thirteen adverse events requiring hospitalization and prolonged hospitalization were reported. The events included 3 cases of bile duct stricture, 2 cases of cholangitis, 2 cases of diarrhea, 1 case of small bowel inflammation, 1 case of pneumonia, 1 case of anorexia, 1 case of fever, 1 case of abdominal pain, and 1 case of peritonitis. Each was a known adverse event and was discharged after mild recovery.

It is believed that improving the R0 resection rate for BR pancreatic cancer will lead to improved prognosis. In this study, 50% was set as the threshold R0 resection rate, and the expected R0 resection rate was 75%. R0 resection rate: 14/21 = 0.666 or higher to reject threshold. 13 patients underwent R0 resection, resulting in an R0 resection rate of 57%, and the primary endpoint was not met. Additional follow-up was performed in March 2023 to estimate 3-year survival. The 3-year survival rate with additional follow-up was 59.2% .

Preoperative S-IROX therapy showed moderate safety and a high completion rate. However, the primary endpoint, R0 resection rate, did not exceed the expected value. The R0 resection rate 56.5% was similar to that of JASPAC05 52%, which utilized preoperative chemoradiotherapy resection for BR. Three of the six patients diagnosed with R1 resection had CIS only at the pancreatic margin. The prognostic impact of CIS at the pancreatic margin is less compared to invasive cancer at the resection margin

May. 27, 2024

No

No special note

https://jrct.mhlw.go.jp/latest-detail/jRCTs031180263

Esaki Minoru

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

mesaki@ncc.go.jp

Maruki Yuta

National Cancer Center Hospital

5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan

+81-3-3547-5293

ymaruki@ncc.go.jp

Complete

May. 24, 2018

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1 Borderline resectable pancreatic cancer
2 Adenocarcinoma or Adenosquamuscarcinoma
3 Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0 or 1
4 No treatment history of chemotherapy and chemoradiotherapy
5 No treatment history of chemotherapy and chemoradiotherapy for pancreatic cancer
6 No diarrhea
7 Orally ingestible
8 Appropriate biliary drainage in case of Obstructive jaundice
9 It has neither homozygote (UGT1A1 6/6,UGT1A1 28/28) nor double heterozygote (UGT1A1 6/28).
10 Adequate organ function
1 White blood cell less than 10.000/mm3
2 Neutrophil more than 1.500/mm3
3 Hemoglobin more than 9.0 g/dL
4 Platelet more than 10000/mm3
5 albumin more than 3.0g/dL
6 Total bilirubin less than 1.5mg/dL
7 AST less than 100U/L
8 ALT less than 100U/L
9 Serum creatinine less than 1.2mg/dL(Male), Serum creatinine less than 1.0mg/dL(Femal)
11 Written informed consent
12 Agree with operation

1 Multiple primary cancers with disease-free period less than 5 years
2 Active infection
3 Fever more than 38
4 Pregnant
5 Uncontrolled mental disease
6 Continuous administration of immunosuppressive drugs including steroids
7 Interstitial pneumonia
8 Serious complications
9 Unstable angina
10 Continuous administration of flucytosine, phenytoin, warfarin potassium
11 Allergy of contrast agent

Both

Pancreatic cancer

S-IROX as down staging chemotherapy for borderline resectable pancreatic cancer given every 2 weeks.
Surgery will be scheduled after 8 times of S-IROX.

Pancreatic cancer

R0 Resection rate

Relapse-free survival, Response rate, Overall survival, adverse events

+81-3-3542-2511

Jan. 12, 2019

none