Concurrent Chemo-radiotherapy With Capecitabine For Unresectable Locally Advanced Pancreatic Carcinoma

Study Overview

Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma

The only curative option for pancreatic cancer patients is surgery, but the patients within 20% of them are possible for a radical surgery. Accordingly, concurrent chemo-radiation therapy is generally used for palliation of unresectable pancreatic cancer patients. So far, the use of 5-fluorouracil (5-FU) was the traditional method of chemotherapy. However, these days, oral anti-cancer medicine, capecitabine(Xeloda®), was developed and considered as an alternative medicine of 5-fluorouracil (5-FU). Furthermore, according to the recent results of clinical trials, the clinical use of capecitabine(Xeloda®) with radiation therapy was proved to be very effective and safe. The purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.

N/A

Pancreatic Cancer

DRUG: Capecitabine (Xeloda®)
RADIATION: Localization, simulation and immobilization

NCCCTS-06-199

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 2008-03-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-04-02
First Submitted that Met QC Criteria 2008-04-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-04-03
First Posted (ESTIMATED) 2008-04-15	Results First Posted N/A	Last Verified 2012-04

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: 1 Primary objectives : To evaluate the tumor response rate, local control rate and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally adva	DRUG: Capecitabine (Xeloda®) Capecitabine is administered orally at a dose of 800 mg/m2 twice daily (total daily dose 1600mg/ m2) continuous regimen regimen during RT (5 days of treatment followed by a 2 day rest: Saturday and Sunday). Capecitabine is given approximately 12 hours apa RADIATION: Localization, simulation and immobilization Radiation dose and planning 1. Total dose 55.8Gy, 28 fractions, 6-7 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to emcompass GTV with a margin of 1-1.5cm. 2. Dose prescription : 90% isodose volume of prescribed dose encompassed PTV 3. T

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

Primary objectives : To evaluate the tumor response rate, local control rate and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally adva

DRUG: Capecitabine (Xeloda®)

Capecitabine is administered orally at a dose of 800 mg/m2 twice daily (total daily dose 1600mg/ m2) continuous regimen regimen during RT (5 days of treatment followed by a 2 day rest: Saturday and Sunday). Capecitabine is given approximately 12 hours apa

RADIATION: Localization, simulation and immobilization

Radiation dose and planning 1. Total dose 55.8Gy, 28 fractions, 6-7 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to emcompass GTV with a margin of 1-1.5cm. 2. Dose prescription : 90% isodose volume of prescribed dose encompassed PTV 3. T

Primary Outcome Measures	Measure Description	Time Frame
all cause mortality		two year

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

Study Contact

Name: Tae Hyun Kim

Phone Number: 82-31-920-0155

Email: krog@ncc.re.kr

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:

There is no evidence of metastatic disease in the major viscera and no peritoneal seeding
Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation
All malignant disease must be encompassable within a single irradiation field (15x15cm maximum)
All patients must have radiographically assessable disease
No previous irradiation to the planned field
Age of ≥18 years
performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score
Required Entry Laboratory Parameters WBC count ≥ 2,000/mm3;(ANC>1,000), hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; total bilirubin ≤ 3.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decreas ≤ 3.0 mg/dL prior to study entry); creatinine ≤ 3.0 mg/dL
Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained.

There is evidence of metastasis in the major viscera or peritoneal seeding.
Age of <18 years
Previous history of RT adjacent to planned field
poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score
pregnant or breast feeding status
previous history of uncontrolled other malignancies within 2 years

Collaborators and Investigators

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

Publications

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