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Phase II trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patients

Phase II trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patients - Phase II trial neoadjuvant chemoradiation therapy with gemcitabine and surgical resection for advanced cholangiocarcinoma patients:NACRAC study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001754
Enrollment
40
Registered
2009-03-04
Start date
2008-12-01
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

cholangiocarecinoma:Stage III and IV of the Japanese General Rules for Surgical and Pathological Studies on Cancer of the Biliary Tract

Interventions

chemoradiation EXRT: 45Gy, 1.8Gy x 25 fr Gemcitabine : 600mg/m2

Sponsors

Hepato-biliary pancreatic surgery,Tohoku University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed as cholangiocarcinoma. And Stage III and IV by the Japanese General Rules for Surgical and Pathological Studies on Cancer of the Biliary Tract 2. Performancestatus(ECOG) is 0 or 1 3. Age are from 20 years old to 74 yeas old 4. survival is expected over 2 months 5. Function of main organ are enough as below, Hb over 10 g/dl. WBC is over 4000/mm3. Neutrophil is over 2000/mm3. Platlet is over1x104mm3. AST and ALT are within 5 times of normal limit. Total bilirubin is within 3 times of normal limit. Creatinine is 1.5 times within normal limit. 6. sign the letter of consent by voluntary agreement

Exclusion criteria

Exclusion criteria: 1. obvious infection 2. fever up (over 38 Celsius) 3. severe complication of heart and lung 4. active double cancer 5. synptom of brain metastases 6. pericardial fluid 7. Previous history of severe drug-induced allergy 8. Pregnant 9. Disqualified by attendig doctor

Design outcomes

Primary

MeasureTime frame
pathological curability

Secondary

MeasureTime frame
safety, disease free survival, over all survival, pathological response

Countries

Japan

Contacts

Public ContactKei Nakagawa

Tohoku University Hospital Hepato-biliary pancreatic surgery,

kein_h11@surg1.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

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