Prospective cohort study to evaluate feasibility and efficacy of systemic chemotherapy followed by carbon-ion radiotherapy for unresectable locally advanced pancreatic cancer

Prospective cohort study to evaluate feasibility and efficacy of systemic chemotherapy followed by carbon-ion radiotherapy for unresectable locally advanced pancreatic cancer - Yu-PANC-01

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049456

Enrollment

Registered

2022-11-08

Start date

2022-11-08

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

Unresectable locally-advanced pancreatic cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histological or cytological confirmation of malignancy. 2. Radiologically diagnosed as pancreatic ductal adenocarcinoma. 3. Unresectable locally-advanced (UR-LA) or Borderline resectable with arterial abutment (BR-A), confirmed by CT-imaging. 4. No obvious distant metastatic findings. 5. Age of over 17 and under 80. 6. Performance status is 0 or 1 (ECOG). 7. Measurable disease. 8. Chemotherapy or Radiotherapy naive for pancreatic cancer. 9. Able to eat orally. 10. No serious comorbidity. 11. No active and ongoing other malignancy. 12. No pregnancy, planing pregnancy or baby. 13. No peripheral neuropathy. 14. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. No histological or cytological confirmation of malignancy. 2. Resectable (R) or Borderline resectable without arterial abutment (BR-PV). 3. Radiological distant metastases. 4. Age of under 18 or over 79. 5. Performance status is 2 or 3 (ECOG). 6. No measurable disease. 7. Previous treatment with chemotherapy or radiotherapy for pancreatic cancer. 8. Unable to eat orally. 9. Serious comorbidity. 10. Active and ongoing other malignancy. 11. Pregnancy, planing pregnancy or baby. 12. Peripheral neuropathy.

Design outcomes

Primary

Measure	Time frame
Disease control rate for 6 months with systemic chemotherapy followed by carbon-ion radiotherapy	—

Secondary

Measure	Time frame
Response rate, Tumor reduction rate, Tumor marker kinetics during the therapy, Overall survival, Progression-free survival, Adverse events, Dose intensity of the agents.	—

Countries

Japan

Contacts

Public ContactMotoi Fuyuhiko

Yamagata University Department of Surgery I

fmotoi@med.id.yamagata-u.ac.jp023-628-5334

Outcome results