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