Overview

Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma

Status:
Unknown status
Trial end date:
2013-06-01
Target enrollment:
0
Participant gender:
All
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 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. The purpose of this trial is to improve the therapeutic effects by using proton therapy and chemotherapy concurrently.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Cancer Center, Korea
Treatments:
Capecitabine
Criteria
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