Status:
UNKNOWN
Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma
Lead Sponsor:
National Cancer Center, Korea
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
- 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.
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 of uncontrolled other malignancies within 2 years
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00658840
Start Date
June 1 2006
End Date
June 1 2013
Last Update
April 3 2012
Active Locations (1)
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1
National Cancer Center Korea
Goyang-si, Gyeonggi-do, South Korea, 410-769