Phase II study of neoadjuvant chemoradiotherapy with gemcitabine and IMRT for patients with resectable pancreatic cancer
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-jRCT1051190064
- Lead Sponsor
- Masui Toshihiko
- Brief Summary
A single-arm exploratory phase II trial of preoperative gemcitabine plus intensity-modulated radiation for resectable pancreatic cancer showed a median overall survival of 49.8 months, more or less equivalent to the current standard of care of 36.1 months for preoperative chemotherapy. The secondary endpoint, AEs, were not serious, indicating that the trial can be performed safely.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 54
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival time from the first day of the protocol therapy
- Secondary Outcome Measures
Name Time Method 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