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

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ClinicalTrials.gov Identifier: NCT00658840
Recruitment Status : Unknown
Verified April 2012 by National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : April 15, 2008
Last Update Posted : April 3, 2012
Sponsor:
Information provided by:
National Cancer Center, Korea

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
Pancreatic Cancer Drug: Capecitabine (Xeloda®) Radiation: Localization, simulation and immobilization Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
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 : June 2006
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2013

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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

  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.




Primary Outcome Measures :
  1. all cause mortality [ Time Frame: two year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00658840


Contacts
Contact: Tae Hyun Kim 82-31-920-0155 krog@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center Korea Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-769
Contact: Tae Hyun Kim    82-31-920-0155    krog@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea

Responsible Party: Tae Hyun Kim, National Cancer Center Korea
ClinicalTrials.gov Identifier: NCT00658840     History of Changes
Other Study ID Numbers: NCCCTS-06-199
First Posted: April 15, 2008    Key Record Dates
Last Update Posted: April 3, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents