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A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

Phase 2
18 Years
70 Years
Open (Enrolling)
Resectable Pancreatic Carcinoma

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Trial Information

A Phase 2 Study of Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

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

- 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

- uncontrolled hypertension

- hepatic cirrhosis( ≥ Child class B)

- interstitial pneumonia, pulmonary adenomatosis

- psychiatric disorder that may interfere with and/or protocol compliance

- unstable diabetes mellitus

- uncontrolled ascites or pleural effusion

- active infection

- Received any investigational drug or agent/procedure, i.e. participation in another
trial within 4 weeks before beginning treatment with study drug

- Pregnant or lactating woman

- Women of child bearing potential not using a contraceptive method

- Sexually active fertile men not using effective birth control during medication of
study drug and up to 6 months after completion of study drug if their partners are
women of child-bearing potential

- Any patients judged by the investigator to be unfit to participate in the study

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete resection rate

Outcome Description:

To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).

Outcome Time Frame:

Within the first 30 days after surgery

Safety Issue:


Principal Investigator

Sang Jae Park, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Center, Korea


Korea: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

December 2013

Related Keywords:

  • Resectable Pancreatic Carcinoma
  • Preoperative chemoradiotherapy with Gemcitabine
  • Carcinoma
  • Pancreatic Neoplasms