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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00658840
• Other study ID #: NCCCTS-06-199
• Status: Unknown status
• Phase: Phase 2
• First received: March 24, 2008
• Last updated: April 2, 2012
• Start date: June 2006
• Est. completion date: June 2013

Study information

• Verified date: April 2012
• Source: National Cancer Center, Korea
• Contact: Tae Hyun Kim
• Phone: 82-31-920-0155
• Email: krog[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 55
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Capecitabine (Xeloda®)
Capecitabine is administered orally at a dose of 800 mg/m2 twice daily (total daily dose 1600mg/ m2) continuous regimen regimen during RT (5 days of treatment followed by a 2 day rest: Saturday and Sunday). Capecitabine is given approximately 12 hours apart and taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).

Radiation:
• Localization, simulation and immobilization
Radiation dose and planning Total dose 55.8Gy, 28 fractions, 6-7 weeks (1.8 Gy/day). A cone down after 45 Gy will be performed to emcompass GTV with a margin of 1-1.5cm. Dose prescription : 90% isodose volume of prescribed dose encompassed PTV The dose-volume histogram (DVH) of targets, such as GTV, CTV, and PTV, and the normal tissues, such as the liver, duodenum, stomach, the kidneys, spinal cord, etc., was calculated.

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Korea	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		two year