Phase II trial of carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer (GUNMA1301)

Phase II trial of carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer (GUNMA1301) - Carbon-ion radiotherapy with Gemcitabine for locally advanced pancreatic cancer (GUNMA1301)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012296

Enrollment

Registered

2013-11-14

Start date

2013-07-01

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

Locally advanced pancreatic cancer

Interventions

Carbon-ion radiation therapy Chemotherapy (Gemcitabine)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically diagnosed pancreatic invasive ductal carcinoma. 2) Locally advanced (unresectable) disease. 3) No distant metastasis except for paraaortic lymphnode. 4) No invasion to mocosal membrane of stomach or intestine. 5) Measureable tumor 6) PS0-2 7) good function of other organs 8) Informed consent

Exclusion criteria

Exclusion criteria: 1) Past history of irradiation to the target region 2) Infection around the target 3) Metalic stent at the bile duct 4) Pleural effusions or ascites 5) Past history of chemotherapy within 4 weeks before start of this treatment 6) Uncontrolled severe complication 7) Active ulcer of stomach or duodenum 8) Active double cancers 9) Interstitial pneumonia 10) In pregnancy or during the lactation preiod 11) Other medical or psychological unsuitable reasons

Design outcomes

Primary

Measure	Time frame
overall survival rate	—

Secondary

Measure	Time frame
Response rate Local control rate at two year Progression free survival rate Acute and late toxicity	—

Countries

Japan

Contacts

Public ContactTatsuya Ohno

Gunma University Gunma University Heavy Ion Medical Center

tohno@gunma-u.ac.jp027-220-8378

Outcome results

None listed

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