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

Phase 1

Recruiting

• Conditions: pancreatic cancer; C535836

• Registration Number: JPRN-jRCT1051230087
• Lead Sponsor: Mizowaki Takashi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-18
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Confirmed pancreatic adenocarcinoma by endoscopic ultrasound-fine needle aspiration.
2. Patients with borderline resectable pancreatic cancer or locally advance pancreatic cancer.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute Grade 3 or higher adverse event non-incident rate which gastrointestinal origin

Secondary Outcome Measures

Name	Time	Method
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