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Trial Title:
Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma
NCT ID:
NCT00658840
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Capecitabine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine (Xeloda®)
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).
Arm group label:
1
Intervention type:
Radiation
Intervention name:
Localization, simulation and immobilization
Description:
Radiation dose and planning
1. 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.
2. Dose prescription : 90% isodose volume of prescribed dose encompassed PTV
3. 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.
Arm group label:
1
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center Korea
Address:
City:
Goyang
Zip:
410-769
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Tae Hyun Kim
Phone:
82-31-920-0155
Email:
krog@ncc.re.kr
Start date:
June 2006
Completion date:
June 2013
Lead sponsor:
Agency:
National Cancer Center, Korea
Agency class:
Other
Source:
National Cancer Center, Korea
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00658840
