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Phase II study of dynamic tumor tracking intensity-modulated radiotherapy in patients with locally advanced pancreatic cancer

Phase II study of dynamic tumor tracking intensity-modulated radiotherapy in patients with locally advanced pancreatic cancer - Phase II study of dynamic tumor tracking IMRT for locally advanced pancreatic cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000017521
Enrollment
25
Registered
2015-07-01
Start date
2015-07-01
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

Intensity-modulated radiotherapy(IMRT)

Sponsors

Kyoto University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Pancreatic cancer pathologically proven with pancreatic juice or biops. 2) Clinical stage IIA, IIB, III (UICC) 3) ECOG PS;0-1 4) Without previous surgical resection for pancreatic cancer or irradiation to upper abdomen 5) adequate oral intake 6) Adequate organ functions; white blood cells >= 3,000/m3 Neutrophil>=2000/m3 platelets >= 100,000/m3 hemoglobin >= 9.0g/dl AST<= 150 U/L ALT<= 150 U/L total bilirubin <= 2.0mg/dL Creatinine <= 1.2mg/dL Albumin >= 3.0 mg/dL Without fever over 38 degree 7) diagnosed as capable of dynamic tumor tracking with inserted fiducial marker 8) Written Informed Consent

Exclusion criteria

Exclusion criteria: 1) Intersitial pneumonia or pulmonary fibrosis 2) previous irradiation to upper abdomen 3) Severe comorbidity 4) Pleural effusion or Ascites 5) Tumor invasion to stomach, duodenum or intestine 6) Patients with double cancer (double cancer or treated cancer with no more than 3-year disease-free period). However, carcinoma in situ or intra-mucosal cancer-equivalent lesion are not to be included in double cancer 7) Severe allergy history to gold 8) Unstable and Uncontrollable diabetic mellitus, or severe collagen disease 9) Woman during pregnancy or breast-feeding, patient who wish pregnancy 10) Psychiatric disease 11) Inappropriate patients for this study judged by physicians

Design outcomes

Primary

MeasureTime frame
1-year freedom from loco-regional progression

Secondary

MeasureTime frame
Loco-regional progression-free survival, overall survival, progression-free survival, the incidence of acute adverse events, the incidence of late adverse events, treatment-related morbidity/early mortality , the accuracy in dynamic tumor tracking technique

Countries

Japan

Contacts

Public ContactYukinori Matsuo

Kyoto University Hospital Department of Radiation Oncology and Image-Applied Therapy

ymatsuo@kuhp.kyoto-u.ac.jp075-751-3417

Outcome results

None listed

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