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

National Cancer Center (NCC)

Status and phase: Unknown; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Capecitabine (Xeloda®); Radiation: Localization, simulation and immobilization

Study type: Interventional

Funder types: Other

Identifiers

NCT00658840

NCCCTS-06-199

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

1

Experimental group

Description:

Primary objectives : To evaluate the tumor response rate, local control rate and compliance (acute and late toxicity, esp. gastrointestinal tract toxicity) of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma Secondary objectives : To evaluate the impact of concurrent chemo-radiotherapy with oral capecitabine in patients with unresectable locally advanced pancreatic carcinoma by analyzing the progression-free survival rate and overall survival rate.

Treatment:

Radiation: Localization, simulation and immobilization

Drug: Capecitabine (Xeloda®)