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Exploratory clinical trial to evaluate the feasibility and efficacy of conversion surgery after systemic chemotherapy followed by carbon ion radiotherapy against locally advanced unresectable pancreatic cancer

Exploratory clinical trial to evaluate the feasibility and efficacy of conversion surgery after systemic chemotherapy followed by carbon ion radiotherapy against locally advanced unresectable pancreatic cancer - Yu-PANC-02

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049457
Enrollment
25
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

Initially locally advanced unresectable pancreatic cancer after chemotherapy followed by carbon-ion radiotherapy with favorable response

Interventions

Curative resection for pancreatic cancer

Sponsors

Faculty of Medicine, Yamagata University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Pre-treatment histological or cytological confirmation of malignancy. 2. Radiologically diagnosed as pancreatic ductal adenocarcinoma before treatment. 3. Unresectable locally-advanced (UR-LA) or Borderline resectable with arterial abutment (BR-A), confirmed by CT-imaging before treatment. 4. No obvious distant metastatic findings. 5. More than 4 months chemotherapy for pancreatic cancer. 6. Carbon ion radiotherapy after chemotherapy described above 5. 7. Disease control after more than 6 months treatment (RECIST=CR, PR, SD). 8. Serum tumor marker decrease after more than 6 months treatment. 9. No distant metastases by staging laparoscopy, including positive peritoneal lavage cytology. 10. Performance status is 0 or 1 (ECOG). 11. No serious comorbidity. 12. No active and ongoing other malignancy. 13. Able to eat orally 14. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. No pre-treatment histological or cytological confirmation of malignancy. 2. Resectable (R) or Borderline resectable without arterial abutment (BR-PV), confirmed by CT-imaging before treatment. 3. Obvious distant metastatic findings. 4. Less than 4 months chemotherapy. 5. No treatment with carbon ion radiotherapy. 6. Without disease control after treatment (RECIST=PD). 7. Serum tumor marker increase after treatment. 8. Distant metastases detected staging laparoscopy after treatment, including positive peritoneal lavage cytology. 9. Performance status is 2 or 3 (ECOG). 10. Serious comorbidity. 11. Active and ongoing other malignancy. 12. Unable to eat orally

Design outcomes

Primary

MeasureTime frame
Postoperative morbidity rate with severe complication and mortality rate

Countries

Japan

Contacts

Public ContactMotoi Fuyuhiko

Yamagata University Department of Surgery I

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

Outcome results

None listed

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