A Phase II Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma
Data Collection
Digestive System Diseases+5
+ Digestive System Neoplasms
+ Endocrine System Diseases
Treatment Study
Summary
Study start date: January 1, 2007
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.4 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location