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A Phase II Study of Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

A Phase II Study of Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma


Inclusion Criteria:



- 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 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 of uncontrolled other malignancies within 2 years

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

all cause mortality

Outcome Time Frame:

two year

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

NCCCTS-06-199

NCT ID:

NCT00658840

Start Date:

June 2006

Completion Date:

June 2013

Related Keywords:

  • Pancreatic Cancer
  • Carcinoma
  • Pancreatic Neoplasms

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