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

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Capecitabine (Xeloda®)

Localization, simulation and immobilization

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

National Cancer Center KoreaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 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.

Outcomes

Primary Outcome Measures

all cause mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT00658840

First Posted

March 24, 2008

Last Updated

April 2, 2012

Sponsor

National Cancer Center, Korea

1. Study Identification

Unique Protocol Identification Number

NCT00658840

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

June 2006 (undefined)

Primary Completion Date

June 2013 (Anticipated)

Study Completion Date

June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Center, Korea

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Capecitabine (Xeloda®)

Intervention Description

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).

Intervention Type

Radiation

Intervention Name(s)

Localization, simulation and immobilization

Intervention Description

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.

Primary Outcome Measure Information:

Title

all cause mortality

Time Frame

two year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tae Hyun Kim

Phone

82-31-920-0155

krog@ncc.re.kr

Facility Information:

Facility Name

National Cancer Center Korea

City

Goyang

State/Province

Gyeonggi

ZIP/Postal Code

410-769

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tae Hyun Kim

Phone

82-31-920-0155

krog@ncc.re.kr

12. IPD Sharing Statement

Learn more about this trial

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

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