Preoperative Chemoradiotherapy With Gemcitabine For Resectable Pancreatic Carcinoma

Study Overview

Preoperative Chemoradiotherapy With Gemcitabine for Resectable Pancreatic Carcinoma

This phase II study is to evaluate the efficacy of preoperative chemoradiotherapy with gemcitabine (400mg/m2, weekly) for resectable pancreatic cancer.

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.

Resectable Pancreatic Carcinoma

RADIATION: chemoradiotherapy with Gemcitabine
RADIATION: Radiation: chemoradiotherapy with Gemcitabine

NCCCTS-10-500

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-04-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2020-04-02
First Submitted that Met QC Criteria 2011-04-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2020-04-06
First Posted (ACTUAL) 2011-04-11	Results First Posted N/A	Last Verified 2020-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Radiation: chemoradiotherapy with Gemcitabine Radiation: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative	RADIATION: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If RADIATION: Radiation: chemoradiotherapy with Gemcitabine Radiation: chemoradiotherapy with Gemcitabine

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Radiation: chemoradiotherapy with Gemcitabine

Radiation: chemoradiotherapy with Gemcitabine All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative

RADIATION: chemoradiotherapy with Gemcitabine

All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If

RADIATION: Radiation: chemoradiotherapy with Gemcitabine

Radiation: chemoradiotherapy with Gemcitabine

Primary Outcome Measures	Measure Description	Time Frame
Complete resection rate	To evaluate the impact of preoperative chemoradiotherapy with gemcitabine by analyzing complete resection rate (R0).	Within the first 30 days after surgery

Secondary Outcome Measures	Measure Description	Time Frame
Clinical outcomes	To investigate the association between radiologic, histopathologic response, complete resection rate of preoperative chemoradiotherapy with gemcitabine and clinical outcomes, such overall survival and disease-free survival.	Up to 3years from a initial follow-up
The association between biomolecular markers and clinical outcomes	To investigate the association between biomolecular markers and clinical outcomes (including tumor response and complete resection rate, etc.)	Up to 3years until study closed
The feasibility and compliance	To evaluate the feasibility and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of preoperative chemoradiotherapy with gemcitabine for resectable pancreatic cancer.	Up to 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Sang-Jae Park, M.D., National Cancer Center, Korea

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record