NIPH Clinical Trials Search

JRCT ID: jRCT1051190064

Registered date:16/10/2019

Phase II study of neoadjuvant chemoradiotherapy with gemcitabine and IMRT for patients with resectable pancreatic cancer

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPancreatic cancer
Date of first enrollment05/07/2016
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)One course of GEM administration (Day 1,8,15, 1000mg /m2) and neoadjuvant chemoradiotherapy of GEM (Day 1,8,15, 1000mg /m2) combined IMRT (3GyX15 times, 45Gy total) following pancreatectomy with lymph node dissection


Primary OutcomeOverall survival time from the first day of the protocol therapy
Secondary OutcomeDisease-free survival (DFS), negative marg in rate (R0 rate), response rate (RR), histological response rate, incidence rate of acute disease, incidence rate of late-onset disease, Risk organ failure rate, treatment-related death rate / early death rate / Grade 4 non-hematological toxicity rate

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 80age old
Include criteria1. Primary tumor is confirmed to be pancreatic cancer from histology or cytology 2. No distant metastasis 3. Cases matching RPC expected to curative resection (R0 or R1). T1-3, stageIA-IIB according to UICC TNM classification 4. Age 20-80 years 5. ECOG Performance status 0 or 1 6. Capable of radical surgery 7. No previous treatment for pancreatic cancer 8. Capable of oral intake No clinical problems in ECG (latest value within 28 days before registration). 9. Main organs functions meet the following criteria Leukocytes >=3500 <12,000/mm3, Neutrophil>= 2000/mm3, Hemog lobin >= 9.0 g /dL, Platelets >= 100,000/mm3, Total bilirubin < 2.0 mg /dL (<= 3.0 mg /dl in biliary drainage case), AST/ALT <= 150 U/L, Serum creatinine <= 1.2 mg /dL, Ccr >=50mL/min 10. Signed and dated informed consent before enrollment.
Exclude criteria1. Interstitial pneumonia or pulmonary fibrosis (latest evaluation by CT within 28 days before reg istration) 2. Prior history of radiation treatment in the upper abdomen and evaluated as inappropriate for the neoadjuvant chemoradiation. 3. Severe comorbidities (heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, paralytic ileus, ileus, uncontrollable diabetes mellitus) 4. Uncontrollable pleural effusion or ascites that needs puncture 5. active malignant tumors (including that without recurrence in the past three years) Intramucosal carcinoma and carcinoma in situ are not dealt as active malignant tumors 6. Breast-feeding or pregnant, possibly pregnant, or women who do not agree to prevent conception, and both men and women without intention to use contraception during the period of the study 7. Cases with severe mental disorders 8. Additional cases the doctor deems inappropriate for the participation of the clinical trial

Related Information


Public contact
Name Toshihiko Masui
Address 54 Shogoin Kawaracho Sakyo Kyoto Japan Kyoto Japan 606-8507
Telephone +81-75-751-4322
Affiliation Kyoto University Hospital
Scientific contact
Name Toshihiko Masui
Address 54 Shogoin Kawaracho Sakyo Kyoto Japan Kyoto Japan 606-8507
Telephone +81-757514322
Affiliation Kyoto University Hospital