Phase II study of dynamic intensity modulated radiotherapy in patients with borderline resectable pancreatic cancer

JRCT ID: jRCTs041220150

Registered date:01/03/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: invasive pancreatic ductal adenocarcinoma
• Date of first enrollment: 12/06/2023
• Target sample size: 42
• Study type: Interventional
• Intervention(s): neoadjuvant gemcitabine plus S-1 based chemoradiotherapy using intensity modulated radiotherapy (IMRT) ; 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 will be treated with intensity modulated radiation therapy. The total radiation dose of 50.4 Gy will be delivered in daily fractions of 1.8 or 2 Gy, 5 times per week.

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 adverse events, rate of curative-intent resection, rate of R0 resection, 2-year and 5-year overall survival rate after curative-intent resection, 2-year and 5-year overall survival rate after initial treatment, rate of postoperative complication, rate of recurrence after surgery, mode of recurrence, reasons why pancreatectomy was evaluated as not indicated, and details of treatment after discontinuation of protocol treatment

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 o r 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. borderline resectable PDAC according to the resectability of Japan Pancreas Society 7th classification based on contrast enhanced multid etector CT imaging.
5. toleable curative resection
6. no previous anti-tumor treatment
7. Eastern Cooperative Oncology G roup performance status, 0, 1
8. adequate hematological, hepatic, renal, and cardiopulmonary functions
9. adequate ability of oral intake
10. written informed consent befor e 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
• Source(s) of Monetary Support: Mie University hospital clinical research scholarship