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

Sponsor
National Cancer Center, Korea (Other)
Overall Status
Unknown status
CT.gov ID
NCT00658840
Collaborator
(none)
55
Enrollment
1
Location
1
Arm
84
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Capecitabine (Xeloda®)
  • Radiation: Localization, simulation and immobilization
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Concurrent Chemo-radiotherapy With Capecitabine for Unresectable Locally Advanced Pancreatic Carcinoma
Study Start Date :
Jun 1, 2006
Anticipated Primary Completion Date :
Jun 1, 2013
Anticipated Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

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.

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.

Outcome Measures

Primary Outcome Measures

  1. all cause mortality [two year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cancer Center Korea Goyang Gyeonggi Korea, Republic of 410-769

Sponsors and Collaborators

  • National Cancer Center, Korea

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00658840
Other Study ID Numbers:
  • NCCCTS-06-199
First Posted:
Apr 15, 2008
Last Update Posted:
Apr 3, 2012
Last Verified:
Apr 1, 2012
Additional relevant MeSH terms:
Pancreatic Neoplasms
Capecitabine

Study Results

No Results Posted as of Apr 3, 2012