A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Resectable Pancreatic Carcinoma
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Complete resection rate
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.
Detailed Description
The primary objective of this study is to evaluate the complete (R0) resection rate for patients with and resectable pancreatic cancer treated with preoperative chemoradiotherapy and curative surgery. An experimental arm that result a complete resection rate of at least 90% would merit further study. With 90% power to reject that null hypothesis that the true complete resection rate is ≤75% with a type I error level of 5%, evaluable 53 patients are required. Considering the 20% unevaluable patients due to the immediate distant metastasis after treatment7, 8, 17 and 10% follow up loss, a total of 64 eligible patients will be enrolled.
Investigators
Sang-Jae Park
Principal Investigator
National Cancer Center, Korea
Eligibility Criteria
Inclusion Criteria
- •Patients with resectable pancreatic adenocarcinoma
- •Age over 18 years old and younger than 70 year old
- •Performance status (ECOG scale): 0-1
- •Adequate organ functions
- •Hb ≥9.0 g/dl
- •ANC ≥1,500/mm3
- •PLT ≥100,000/mm3
- •Liver function: Total Bilirubin ≤3.0 mg/dl AST/ALT/ALP ≤3× upper limit of normal
- •Creatinine ≤1.5 ULN
- •Patients should sign a written informed consent before study entry.
Exclusion Criteria
- •Tumor type other than adenocarcinoma
- •Unresectable for resection on preoperative evaluation
- •Other primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- •Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy)
- •Prior radiotherapy
- •Major surgery within 4 weeks prior to study treatment
- •Serious illness or medical conditions, as follows;
- •congestive heart failure (NYHA class III or IV)
- •unstable angina or myocardial infarction within the past 6 months,
- •significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
Outcomes
Primary Outcomes
Complete resection rate
Time Frame: Within the first 30 days after surgery
To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).
Secondary Outcomes
- Clinical outcomes(Up to 3years from a initial follow-up)
- The feasibility and compliance(Up to 1 year)
- The association between biomolecular markers and clinical outcomes(Up to 3years until study closed)