MedPath

PENETRATE

Phase 3
Recruiting
Conditions
pancreatic cancer
Registration Number
JPRN-jRCT2080225361
Lead Sponsor
-
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
recruiting
Sex
All
Target Recruitment
216
Inclusion Criteria

1) Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.
2) Patients who confirmed unresectable locally advanced or borderline resectable pancreatic cancer
3) The longest diameter of tumor does not exceed 10 cm by CT image
4) No sign of direct tumor invasion into gastrointestinal tract
5) Age 20 years old or older
6) Performance Status:0-1(ECOG)
7) No past history of surgery or chemotherapy for pancreatic cancer
8) No past history of radiation therapy to the abdomen
9) Sufficient organ functions

Exclusion Criteria

1) Synchronous multiple cancers
2) Infectious disease to be treated
3) Past history of systemic steroid therapy (>10 mg/body of prednisolone) within 14 days
4) Active peptic ulcer
5) Interstitial pneumonia, pulmonary fibrosis, or inflammatory lung disease confirmed by medical history or imaging test
6) Pleural, pericardial, or abdominal effusion

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
efficacy<br>Overall Survival
Secondary Outcome Measures
NameTimeMethod
efficacy<br>Progression Free Survival, Response rate etc<br>safety<br>Incidence of Adverse event, Incidence of Serious adverse event etc
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