Phase II study of dynamic tumor tracking IMRT in patients with locally advanced pancreatic cancer

Phase 1

• Conditions: Pancreatic cancer

• Registration Number: JPRN-jRCTs051180237
• Lead Sponsor: Mizowaki Takashi

Brief Summary

The first and 25th case was registered on 3rd/July/2015, and 18th/November/2018 respectively. Eighteen, three, three and one patients were registered at Kyoto university, Kobe City Medical Center General Hospital, Kyoto-Katsura Hospital, and Tokyo Metropolitan Komagome Hospital, respectively.The median age was 69 years(range; 52-77) and 13 patients were males. One-year FFLP was 75.3 %. At 1 year, LPFS, PFS and PFS were, and DDFS were 56%, 44%, 60%, respectively

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-30
• Study Completion: 2020-03-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 25

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified