Study Of Respiratory Gated Proton Beam Radiotherapy For Inoperable Pancreas Carcinoma

Study Overview

Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas 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. Proton therapy is a new radiation therapy which remaining energy is released when they reach the tumor, delivering the most effective dose of radiation and which can minimize the exposure to normal tissues. The purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.

N/A

Pancreatic Cancer

RADIATION: Respiratory gated proton beam radiotherapy

NCCCTS-07-226

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 2011-07-07
First Submitted that Met QC Criteria 2008-04-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2011-07-08
First Posted (ESTIMATED) 2008-04-15	Results First Posted N/A	Last Verified 2011-07

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

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

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.

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:

Pathologically confirmed adenocarcinoma of the pancreas or a serum CA19-9 level higher than normal limits and an pancreas cancer-compatible radiological features in one or more in CT/MRI/PET scans
Unresectable disease base on institutional standard criteria of unresectability or recurrent disease following radical surgery. 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 Labortory Parameters:

WBC count ≥ 2,000/mm3
hemoglobin level ≥ 7.5 g/dL
platelet count ≥ 100,000/mm3
total bilirubin ≤ 2.0 mg/dL (Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should be decreased ≤ 2.0 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 uncontrolled other malignancies within 2 years

Collaborators and Investigators

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

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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Clinical Trial Record