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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051230087
Enrollment
10
Registered
2023-08-18
Start date
2023-11-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic cancer

Interventions

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.

Sponsors

Mizowaki Takashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Acute Grade 3 or higher adverse event non-incident rate which gastrointestinal origin

Secondary

MeasureTime frame
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

Contacts

Public ContactTakahiro Iwai

Kyoto University Hospital

takaiwai@kuhp.kyoto-u.ac.jp+81-75-751-3762

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026