A Phase II Study of Combine Modality Therapy in Locally Advanced Pancreatic Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Health Research Institutes, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Chang Gung Memorial Hospital
National Taiwan University Hospital
Mackay Memorial Hospital
China Medical University Hospital
National Cheng-Kung University Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00149578
First received: September 7, 2005
Last updated: May 16, 2007
Last verified: May 2007
  Purpose

Induction chemotherapy will be administered every 2 weeks for 6 cycles (about 3 months). Patients who have radiological evidence of progressive disease will be shifted to salvage chemotherapy. Patients who have responsive or stable disease after induction chemotherapy will receive concurrent chemoradiotherapy 3-4 weeks after the last dose of induction chemotherapy. Surgical evaluation will be performed 4-6 weeks after the completion of chemoradiotherapy. Patients who have resectable disease will undergo surgical resection. Postoperative adjuvant chemotherapy with GOFL for 6 cycles will be given for those who have curative resection. Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy of GOFL till disease progression or unacceptable toxicity.


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine Oxaliplatin 5FU and Leucovorin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 Followed by Concurrent Chemotherapy With Radiotherapy in Locally Advanced Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • The primary end point is to evaluate the local response rate after induction chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer.
  • chemotherapy and concurrent chemoradiotherapy in locally advanced pancreatic cancer. .

Secondary Outcome Measures:
  • The secondary end points are to evaluate the distant metastasis rate and time to tumor progression, overall survival time and quality of life after induction

Estimated Enrollment: 45
Study Start Date: October 2004
Estimated Study Completion Date: October 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients must have histologically or cytologically confirmed adenocarcinoma of pancreas.
  2. Patients must have locally advanced pancreatic cancer.
  3. Patients must have unresectable pancreatic cancer evaluated by radiologist and/or surgeon according to either abdominal CT or MRI, or intra-operative findings.

    • Locally advanced unresectable disease was defined by CT or MRI images as low-density tumor (primary and/or lymphadenopathy) with

      1. extension to the celiac axis or superior mesenteric artery,
      2. occlusion of the superior mesenteric-portal venous confluence
      3. aortic, inferior vena cava (IVC) invasion or encasement
      4. invasion of SMV below transverse mesocolon
      5. rib, vertebral invasion
  4. Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. See section 8.2 for the evaluation of measurable disease.
  5. Age >20 years. Because no dosing or adverse event data are currently available on the use of study agents in patients <20 years of age, children are excluded from this study.
  6. ECOG performance status 0-2; see Appendix A.
  7. Patients must have normal organ and marrow function as defined below:

    • absolute neutrophil count >1,500/mL
    • platelets >100,000/mL
    • total bilirubin <3X institutional upper limit of normal
    • ALT(SGPT) <5 X institutional upper limit of normal
    • creatinine within normal institutional limits or creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  8. Patients who present with jaundice, temporary or permanent internal / external drainage before enrollment will be allowed.
  9. The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  10. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  1. Patients with distant metastases are not eligible.
  2. Patients may not be receiving any other investigational agents.
  3. Patients who have had prior chemotherapy or radiotherapy are not eligible.
  4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents used in the study.
  5. Patients who have above grade II peripheral neuropathy.
  6. Patients who had non-curable second primary malignancy.
  7. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  8. Pregnant women are excluded from this study because the study agents has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated with the study agents.
  9. Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with study agent administered during the study. Appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149578

Contacts
Contact: Yueh-Ling Ho, RN 886-2-26534401 ext 25155 ylho@nhri.org.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 333
Contact: Hsiu-Po Wang, M.D.    886-2-23123456    whp@ha.mc.ntu.edu.tw   
Principal Investigator: Jen-Shi Chen, M.D.         
Chang Gung Memorial Hospital Recruiting
Tao-Yuan, Taiwan
Contact: Jen-Shi Chen , M.D.    886-3-3286778    fong0301@ms18.hinet.net   
Principal Investigator: Hue-Chang Tsai, M.D.         
Principal Investigator: Pin-Wen Lin, M.D.         
Principal Investigator: Cheng-Chung Wu, M.D.         
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital
National Taiwan University Hospital
Mackay Memorial Hospital
China Medical University Hospital
National Cheng-Kung University Hospital
Investigators
Study Chair: Hui-Ju Ch’ang, M.D. Pancreatic Cancer Disease Committee of Taiwan Cooperative Oncology Group
Study Chair: Li-Tzong Chen, Ph.D. Pancreatic Cancer Disease Committee of Taiwan Cooperative Oncology Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00149578     History of Changes
Other Study ID Numbers: T1204
Study First Received: September 7, 2005
Last Updated: May 16, 2007
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
pancreatic cancer
gemcitabine
oxaliplatin
5-Fluorouracil
radiation

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Leucovorin
Gemcitabine
Oxaliplatin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 01, 2014