Randomized phase II trial of neoadjuvant Gemcitabine/S-1 based chemoradiotherapy for potentially resectable pancreatic ductal adenocarcinoma

JRCT ID: jRCTs041200079

Registered date:21/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: invasive pancreatic ductal adenocarcinoma
• Date of first enrollment: 28/01/2021
• Target sample size: 70
• Study type: Interventional

Intervention(s)

Test group: neoadjuvant gemcitabine plus S-1 based chemoradiotherapy; Patients receive orally S-1twice daily at a dose of 60mg/m2/day on days 1 through 21 of a 28-day cycle and an infusion of gemcitabine at a dose of 600 mg/m2 on days 8, 22, 36, and 50. Patients were treated with 3-dimensional conformal radiotherapy. The total radiation dose of 45 or 50.4 Gy was delivered in daily fractions of 1.8 or 2 Gy, 5 times per week.

Control group: neoadjuvant gemcitabine plus S-1 chemotherapy; Patients receive gemciabine at a dose of 1000mg/m2 on days 1 and 8 plus S-1 orally twice daily at a dose according to the BSA (less than 1.25 m2, 80mg/day; 1.25 or more to less tan 1.5, 100mg/day; 1.5 or more, 120mg/day) on days 1 through 14 of a 21 day cycle.

Outcome(s)

• Primary Outcome: histological response (Grade 1, 2, 3, 4) in the resected specimens according to the Japan Pancreas Society 7th classification
• Secondary Outcome: radiographic response according to revised RECIST guideline, rate of curative-intent resection, degree of residual tumor, 2-year and 5-year overall survival rate, rate of postiopeative complication, rate of recurrence after surgery, mode of recurrence

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Both

Include criteria

1. age at the time of registry is 20 or more, 79 or less
2. newly diagnosed invasive pancreatic ductal adenocarcinoma (PDAC) confirmed by imaging study and histological or cytological studies.
3. no distant metastasis
4. potentially resectable PDAC according to the resectability of Japan Pancreas Society 7th classification based on contrast enhanced multidetector CT imaging.
5. toleable curative resection
6. no previous anti-tumor treatment
7. Eastern Cooperative Oncology Group performance status, 0, 1
8. adequate hematological, hepatic, renal, and cardiopulmonary functions
9. adequate ability of oral intake
10. written informed consent before enrolling the study

Exclude criteria

Patients who:
1) is allergic to the chemotherapeutic agents.
2) has pulmonary fibrosis or intestinal pneumonia.
3) has active infectious disease.
4) has simulatenous active cancer.
5) is plegnant or has possibility to become pregnant during the study.
6) is considered ineligible for enrolling the study by the principal investigator or sub-investigator.

Related Information

• Primary Sponsor: Mizuno Shugo