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Phase II study of preoperative intensity modulated radiotherapy with gemcitabine and S-1 in patients with locally advanced pancreas cancer

Phase II study of preoperative intensity modulated radiotherapy with gemcitabine and S-1 in patients with locally advanced pancreas cancer - Preoperative IMRT with gemcitabine and S-1 in patients with pancreas cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000008614
Enrollment
48
Registered
2012-08-04
Start date
2016-04-30
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

Pancreas cancer

Interventions

Gemcitabine, S-1, Intensity modulated radiation therapy

Sponsors

3rd department of surgery Tokyo Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pathologically or cytlogically proven diagnosis of pancreas cancer. 2) A CT or A MRI with contrast of the thorax, abdomen and pelvis exclude distance metastases and peritoneum dissemination. 3) Zubroad performance status is 0-2. 4) Patients have not prior radiotherapy to upper abdomen. 5) Patients must provide clinical condition and have the ability to comprehend and informed consent prior to study entry.

Exclusion criteria

Exclusion criteria: 1) Patients have four months or less life expectancy. 2) Patients have severe co-morbidities disease. 3) Woman of child bearing potential, expectant or nursing woman. 4) Patients have a history of severe drug allergy. 5) Patients have synchronous active cancer. 6) Patients had distant metastases after induction chemotherapy.

Design outcomes

Primary

MeasureTime frame
Overall survival

Secondary

MeasureTime frame
Resection rate Tumor response rate Local recurrence rate Progression free survival Adverse event rate QOL

Countries

Japan

Contacts

Public ContactYuichi Nakakawa

Tokyo Medical University 3rd department of surgery

naga@tokyo-med.ac.jp

Outcome results

None listed

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