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A phase I clinical trial of carbon ion radiotherapy and concurrent gemcitabine

A phase I clinical trial of carbon ion radiotherapy and concurrent gemcitabine - Preoperative carbon ion radiotherapy and chemothrapy for patients with preoperative

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010120
Enrollment
10
Registered
2013-02-26
Start date
2012-05-08
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

Pancreatic Cancer

Interventions

2 weeks Carbon ion radiotherapy: 36.8 GyE / 8 fractions Chemotherapy: weekly gemcitabine 1000 mg / m2 for 3 weeks.

Sponsors

Research Center Hospital for Charged Particle Therapy National Institute of Radiological Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1)Union for International Cancer Control (UICC) StageI- IIB invasive ductal carcinomas of the pancreas 2)Pathologically confirmed invasive ductal carcinomas 3)Patients with no histories of prior chemotherapy or pelvic radiotherapy for pancreasl cancer 4)Tumor size <= 15cm 5)The tumor had to be grossly measurable. 6)Age <= 80 years 7)Performance status 0 - 1 8)Normal organ function WBC >= 4000/mm3 neutrophil>= 2000/mm3 Hb >= 9.0g/dl Plt>= 100,000/mm3 T-Bil.<= 3.0mg/dl, AST(GOT) and ALT(GPT) <= 100IU/dl Cre <= 1.2mg/dl 9)Written informed consent

Exclusion criteria

Exclusion criteria: 1)History of abdominal radiotherapy 2)Metallic stent for obstructive jaundice 3)Digestive tracts invasion 4)Severe complicating illness 5)Histoly of other malignancies within 2 years 6)Active and Severe infection 7)medical, psychological or others reason that primary doctor think ineligible

Design outcomes

Primary

MeasureTime frame
Acute toxicity of organ at risks

Secondary

MeasureTime frame
Primary response rate by recommended dose in 6 months after treatment

Countries

Japan

Contacts

Public ContactShigeru Yamada

National Institute of Radiological Sciences Research Center Hospital for Charged Particle Therapy

yamada.shigeru@qst.go.jp043-206-3306

Outcome results

None listed

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