Skip to content

Examination of the safety and usefulness of preoperative chemotherapy and radiation therapy for locally advanced pancreatic cancer (Phase I / II)

Examination of the safety and usefulness of preoperative chemotherapy and radiation therapy for locally advanced pancreatic cancer (Phase I / II)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031200325
Enrollment
58
Registered
2021-01-27
Start date
2021-01-27
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

Locally advanced pancreatic cancer

Interventions

As a general rule, the first course is hospitalized and performed, but after the second course, outpatient treatment is possible at the discretion of the attending physician while observing the patien

Sponsors

Uwagawa Tadashi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who have been confirmed by histological or cytological examination to have pancreatic cancer. 2) Patients with locally advanced pancreatic cancer who do not have distant metastasis and the tumor has spread to the surrounding arteries and veins, making curative resection difficult. 3) Patients who have not received prior treatment for this disease prior to enrollment 4) Patients whose age at registration is 20 years or older and under 80 years old 5) Patients with Performance status (ECOG) of 0,1 6) Patients who are expected to survive for more than 3 months from the start of treatment 7) Patients who retain the functions of major organs (bone marrow, liver, kidneys, lungs, etc.) 8) Patients with sufficient urine output 9) Patients who can take orally 10) Patients with written consent

Exclusion criteria

Exclusion criteria: 1) Patients with non-curative factors during radical resection 2) Patients with overt pulmonary fibrosis or interstitial pneumonia 3) Patients with active infections (HB, HCV, HIV infections, etc.) 4) Patients with heart failure, angina, arrhythmia and myocardial infarction within 6 months of onset that are difficult to control despite treatment 5) Patients with uncontrollable diabetes 6) Patients with watery diarrhea 7) Patients using flucytosine and phenytoin 8) Pregnant women, lactating and patients with or willingness to become pregnant 9) Patients with severe drug allergies 10) Patients with active double cancer (not applicable to cases 5 years after complete cure) 11) Patients with other serious complications 12) Patients with severe neuropsychiatric symptoms and renal disorders 13) Patients with hearing impairment 14) Chickenpox patients 15) Patients with prior treatment history for this disease 16) Other patients who the doctor in charge judged to be inappropriate for conducting this study safely

Design outcomes

Primary

MeasureTime frame
Optimal radiation dose Transition rate to radical surgical resection

Secondary

MeasureTime frame
Incidence of adverse drug/radiation reactions Progression-free survival in patients with inoperable conversion and BR pancreatic cancer inoperable Recurrence free survival in patients undergoing Conversion surgery and BR pancreatic cancer surgery Response rate Disease control rate 1-year and 2-year survival rates Tumor markers: Changes in serum CEA, CA19-9, DUPAN, etc.

Contacts

Public ContactTadashi Uwagawa

The Jikei University Hospital

uwagawa@jikei.ac.jp+81-3-3433-1111

Outcome results

None listed

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