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

JRCT ID: jRCT1051190064

Registered date:16/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 05/07/2016
• Target sample size: 120
• Study type: Interventional
• 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

Outcome(s)

• Primary Outcome: Overall survival time from the first day of the protocol therapy
• Secondary Outcome: Disease-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
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Masui Toshihiko
• Secondary ID(s): UMIN 000022303