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Clinical trial on the Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy for elderly patients with advanced pancreatic cancer

Clinical trial on the Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy for elderly patients with advanced pancreatic cancer - Feasibility and Efficacy of nab-PTX+GEM combination chemotherapy for elderly patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000018907
Enrollment
25
Registered
2015-09-04
Start date
2015-09-07
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

None listed

Sponsors

Kitasato University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients who had been already obtained informed consent for nab-PTX+GEM combination chemotherapy before registration time; histologically proven unresectable pancreatic adenocarcinoma or adenosquamous carcinoma; age more than 75 years; an expected survival period of more than 3 months; Eastern Cooperative Oncology Group performance status 0-1; measurable lesion by RECIST.(Ver.1.1); no prior chemotherapy and radiotherapy; adequate organ function as evidenced by the following laboratory studies within 7 days prior to enrollment (leukocyte count </=12,000/mm3, neutrophil count >= 1.500/mm3, hemoglobin >= 9.0 g/dl, platelets >= 100,000/mm3, AST/ALT </= ULN x 2.5 U/L, total bilirubin </= ULN x 1.25 mg/dL, creatinine clearance>= 60 ml/min, CRP </=1.5 mg/dL, HbA1c <8.4%,); no abnormal electrocardiogram; patients with agreement of this cohort study.

Exclusion criteria

Exclusion criteria: age less than 75 years; impossible to use both iodine and gadolinium due to being allergic to contrast agent; severe mental disorders; any other cases who are regarded as inadequate for study enrollment by investigators.

Design outcomes

Primary

MeasureTime frame
adverse events, completion rates of two cycles chemotherapy, relative dose intensity, postponed rates of chemotherapy, reduced rates of dose, disease control rate and progression free survival

Countries

Japan

Contacts

Public ContactKosuke Okuwaki

Kitasato University School of Medicine Department of Gstroenterology

kokuwaki@kitasato-u.ac.jp81-42-778-8111

Outcome results

None listed

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