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Induction Chemotherapy With Gemcitabine and Cisplatin Followed by CCRT for Unresectable Pancreatic Carcinoma

This study is currently recruiting participants.
Verified May 2012 by National Cancer Center, Korea
Sponsor:
Information provided by (Responsible Party):
Woojin Lee, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01593475
First received: May 1, 2012
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  Purpose

This phase II trial chose the induction chemotherapy with gemcitabine and cisplatin followed by Chemoradiotherapy (CRT) with gemcitabine to optimize the treatment for pancreas cancer patients with locally advanced disease and the purpose of this trial is to evaluate the efficacy of induction CT with gemcitabine and cisplatin followed by CRT for unresectable pancreatic carcinoma.


Condition Intervention Phase
Pancreatic Carcinoma Non-resectable
 Radiation: Induction Chemotherapy with CCRT
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Induction Chemotherapy With Gemcitabine and Cisplatin Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Pancreatic Carcinoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Center, Korea:

Primary Outcome Measures:
  • feasibility and compliance [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    to evaluate acute and late toxicity of induction chemotherapy with gemcitabine and cisplatin followed by chemoradiotherapy for unresectable pancreatic cancer.


Secondary Outcome Measures:
  • overall survival [ Time Frame: Up to 3years until study closed ] [ Designated as safety issue: No ]
    To evaluate the impact of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy

  • disease-free survival. [ Time Frame: participants will be followed for the duration of disease free, an expected average of 9 months ] [ Designated as safety issue: No ]
    To investigate the association between tumor response of induction chemotherapy with gemcitabine and cisplatin followed by concurrent chemoradiotherapy and clinical outcomes


Estimated Enrollment: 34
Study Start Date: March 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: induction CTx followed by CCRT Radiation: Induction Chemotherapy with CCRT
In one cycle (4-weeks), gemcitabine 1,000 mg/m2 will be given by 30-minute intravenous infusion on days 1, 8, and 15, and 1 hour infusion of CDDP was administered at a dose of 25 mg/m2 weekly diluted in 500 mL of normal saline to ensure adequate hydration 1 hour before the administration of gemcitabine. Gemcitabine 300mg/m2 will be given by 30-minute intravenous infusion weekly during RT and CRT will be started within 3 weeks after completion of 2 cycles of induction chemotherapy

Detailed Description:

The primary endpoint is feasibility and compliance of induction chemotherapy with gemcitabine and cisplatin followed by CRT for locally advanced unresectable pancreatic cancer. Previous studies showed that approximately 20% of patients with locally advanced disease developed the early distant metastasis.[6, 7] Thus, it will be expected that at least 80% of total patients will be eligible for induction chemotherapy after completion of induction chemotherapy. An experimental arm that result a compliance of 80% would merit further study. If the true compliance rate of the patients who will eligible for CRT is ≤ 60%, null hypothesis will be rejected with a power of 80% and a type I error of 5%. Thus, the required number of evaluable patients is 24. Considering the 10% follow-up loss and 20% distant metastasis rate after induction chemotherapy, a total of 34 eligible patients will be enrolled.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed adenocarcinoma of the pancreas
  • Unresectable locally advanced disease base on institutional standard criteria of unresectability disease following radical surgery. 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 1 on the Eastern Cooperative Oncology Group (ECOG) score
  • Required Entry Laboratory Parameters WBC count ≥ 1,000/mm3; 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 decrease ≤ 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.
  • Signed informed consent form prior to study entry

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 2 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593475

Contacts
Contact: Tae Hyun Kim, Ph.D +82-31-920-1725 k2onco@ncc.re.kr

Locations
Korea, Republic of
National Cancer Center, Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Tea Hyun Kim, Ph.D     +82-31-920-1725     k2onco@ncc.re.kr    
Principal Investigator: Woo Jin Lee, Ph.D            
Sub-Investigator: Tae Hyun Kim, Ph.D            
Sub-Investigator: Sang Myeong Woo, M.D            
Sub-Investigator: Sang Jae Park, Ph.D            
Sub-Investigator: Sung Sik Han, Ph.D            
Sub-Investigator: young Hwan Ko, Ph.D            
Sub-Investigator: Eun Kyeong Hong, Ph.D            
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
Principal Investigator: Woo Jin Lee, Ph.D National Cancer Center, Korea
  More Information

No publications provided

Responsible Party: Woojin Lee, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01593475     History of Changes
Other Study ID Numbers: NCCCTS-11-567
Study First Received: May 1, 2012
Last Updated: May 9, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Cisplatin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013