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A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer

A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer - A phase 2 study of induction chemotherapy followed by chemoradiotherapy for patients with borderline resectable pancreatic cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034410
Enrollment
40
Registered
2018-10-10
Start date
2019-03-25
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

A total of three courses of nab-Paclitaxel and Gemcitabine followed by TS-1 with concurrent radiotherapy of 45Gy for 5 weeks

Sponsors

Keio University School of Medicine
Lead Sponsor
Department of Surgery, Tochigi Medical Center Department of Surgery, Ichikawa General Hospital, Tokyo Dental College Department of Surgery, Tokyo Medical Center Department of Surgery, Saitama National Hospital Department of Surgery, Hiratsuka City Hospital Department of Surgery, Fussa Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Histologically proven or radiologically confirmed pancreatic cancer 2) No prior treatment for pancreatic cancer 3) Age between 20 to 85 4) ECOG performance status 0/1 5) White blood cell count above 3000/mm3 Neutrophil count above 1000/mm3 Platelet count above 100000/mm3 Hemoglobin above 8.0 g/dl Total billirubin below 3.0 mg/dl AST, ALT below 150 IU/L Creatinine below 1.5 mg/dl 6) No exclusion criteria 7) Proper informed consent

Exclusion criteria

Exclusion criteria: 1) Contraindication of nab-PTX, GEM, TS-1 2) Pleuritic effusion refractory to diuretics 3) Presence of distant metastasis 4) Presence of concurrent advanced cancer 5) Presence of clinically obvious infection 6) Prior radiotherapy to abdominal lesions 7) Previous history of myocardial infarction within three months 8) Severely mental retardation 9) Current status of pregnancy and lactation, or the possibility of these statuses.

Design outcomes

Primary

MeasureTime frame
R0 resection rate

Secondary

MeasureTime frame
Relapse-free survival Overall survival Treatment completion rate Adverse effect Pathological response

Countries

Japan

Contacts

Public ContactMinoru Kitago

Keio University School of Medicine Department of Surgery

dragonpegasus@keio.jp0333531211

Outcome results

None listed

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