Randomized phase II study comparing Gemcitabine chemoradiotherapy with Gemcitabine chemotherapy for unresectable locally advanced pancreatic cancer.

Randomized phase II study comparing Gemcitabine chemoradiotherapy with Gemcitabine chemotherapy for unresectable locally advanced pancreatic cancer. - Randomized phase II study comparing Gemcitabine chemoradiotherapy with Gemcitabine chemotherapy for unresectable locally advanced pancreatic cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012253

Enrollment

110

Registered

2013-11-10

Start date

2000-01-01

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

Unresectable locally advanced pancreatic cancer.

Interventions

Group A : Gemcitabine 1,000mg/m2 is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. Group B : Gemcitabine 600mg/m2 is administered with 30 min intravenous infusion on day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer. 2. Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below. a: Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.) b: Involving over the merging section of portal-SMV. c: No distal metastasis with diagnostic imaging. d: Confirmed by CT image performed with in four weeks before registration. 3. Performance Status:0-1(ECOG) 4. Patients of age =>20 and 80> 5. Sufficient organ functions. (1) neutrophils >=1,500/mm3 (2) platelets >=100,000/mm3 (3) hemoglobin >=9.0g/dl (4) AST(GOT)/ALT(GPT) <=150IU (5) total bilirubin <=2.0mg/dl (or <=3.0mg/dl if biliary drainage were present) (6) serum creatinine <=1.2mg/dl (7) creatinine clearance>=60ml/min 6. Life expectancy more than 3 months. 7. Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. 2) Watery diarrhea 3) Severe infection 4) Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 5) Massive pleural or abdominal effusion. 6) Metastasis to central nervous system. 7) Active synchronous or metachronous malignancy other than carcinoma in situ. 8) Regular use of frucitocin, fenitoin or warfarin 9) Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 10) Severe mental illness 11) Patients who are judged inappropriate for the entry into the study by the investigator.

Design outcomes

Primary

Measure	Time frame
Two year survival rate	—

Secondary

Measure	Time frame
Progression free survival(PFS) Overall Survival(OS) Adverse events Response rate	—

Countries

Japan

Contacts

Public ContactTatsuya Ioka

Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology

ioka-ta@mc.pref.osaka.jp06-6972-1181

Outcome results

None listed

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