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Panc dose escalation

A phase I dose escalation study of carbon-ion radiotherapy for pancreatic cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032210292
Enrollment
24
Registered
2021-09-02
Start date
2022-03-01
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 pancreatic cancer

Interventions

Carbon-ion radiotherapy is performed using medical heavy particle accelerator (HIMAC) installed at QST Hospital. The irradiation field includes the tumor identified by medical imaging examinations. Po

Sponsors

Yamada Shigeru
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Histologically or clinically diagnosed primary pancreatic tumor (2) No indication for curative resection or no desire for surgery (3) Has evaluable disease (4) No obvious distant metastasis (5) Age at the time of enrollment is 20 years or older (6) Have a performance status (EGOG) of 0-2 (7) No prior surgical resection*1 or radiation therapy for pancreatic cancer *1: Excluding simple laparotomy, gastrojejunostomy, and bile duct jejunal anastomosis (8) Patients who are estimated to have a chance of survival for at least 3 months (9) Patient's written consent for participation in the study has been obtained.

Exclusion criteria

Exclusion criteria: (1) Tumor involvement in the mucosal surface of the gastrointestinal tract (2) A metal stent has been inserted. (3) Active gastroduodenal ulcer is present (4) Active and refractory infection in the irradiated area (5) Patient has serious complications (6) History of radiation therapy in the area (7) It is judged that it is difficult to carry out this study for medical, psychological, or other reasons. Other reasons that the physician deems inappropriate for enrollment in this study (8) Adult who lacks the capacity to give consent (9) Eligible for the clinical trial of [A clinical trial for efficacy and safety on carbon-ion radiotherapy and concurrent GEM chemotherapy for locally advanced pancreatic cancer] (jRCT1031190131)

Design outcomes

Primary

MeasureTime frame
Acute adverse reactions

Secondary

MeasureTime frame
Late adverse reactions, local control rate, overall survival period

Contacts

Public ContactMakoto Shinoto

QST Hospital, National Institutes for Quantum Science and Technology

shinoto.makoto@qst.go.jp+81-43-206-3306

Outcome results

None listed

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