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

JRCT ID: jRCTs051180237

Registered date:30/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 30/09/2015
• Target sample size: 25
• Countries of recruitment: Japan Only,Japan
• Study type: Interventional

Intervention(s)

Chemotherapy
Radiotherapy

Outcome(s)

• Primary Outcome: Freedom From Loco-regional Progression
• Secondary Outcome: Loco-regional Progression-free survival, Progression free survival, Overall survival, Acute toxicity, late toxicity

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Mizowaki Takashi
• Secondary Sponsor: Matsuo Yukinori