Clinical trial to evaluate the safety and feasibility of online adaptive radiotherapy using cone-beam CT for pancreatic cancer

JRCT ID: jRCT1051230087

Registered date:18/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: pancreatic cancer
• Date of first enrollment: 13/11/2023
• Target sample size: 10
• Study type: Interventional

Intervention(s)

On-line adaptive intensity-modulated radiotherapy to the tumor and draining lymph node at risk;
(Borderline resectable pancreatic cancer) 42 Gy/15 fr
(Locally advanced pancreatic cancer) 48 Gy/15 fr

Gemcitabine; administered by intravenous drip infusion every week at a dose of 1000 mg/m2 for 3 weeks.

Outcome(s)

• Primary Outcome: Acute Grade 3 or higher adverse event non-incident rate which gastrointestinal origin
• Secondary Outcome: Completion probability of treatment protocol, Adverse event rate except for gastrointestinal origin, Treatment time, Intra-fractional motion of organ, Inter-fractional motion of organ, Dosimetric parameters in adaptive and non-adaptive plan, The contour difference between in treatment and after treatment, The contour difference between operators, The optimal margin of organ at risk in oART

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Confirmed pancreatic adenocarcinoma or adenosquamous cell carcinoma by endoscopic ultrasound-fine needle aspiration. Or cytology of class IV or V and imaging findings consistent with adenocarcinoma or adenosquamous cell carcinoma.
2. Patients with borderline resectable pancreatic cancer or locally advance pancreatic cancer.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclude criteria

1. Patients who have received radiotherapy to upper abdomen.
2. Tumor with direct invasion to stomach, duodenum, or small intestine.
3. Patients who cannot be treated expiratory breath-hold technique.

Related Information

• Primary Sponsor: Mizowaki Takashi