Status:
TERMINATED
Study of Respiratory Gated Proton Beam Radiotherapy for Inoperable Pancreas Carcinoma
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00658801
Start Date
January 1 2007
End Date
February 1 2010
Last Update
July 8 2011
Active Locations (1)
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1
National Cancer Center Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769