A Phase III Study of Pancreatic Cancer

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Taiwan University Hospital
Chang Gung Memorial Hospital
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00994721
First received: March 26, 2008
Last updated: October 11, 2009
Last verified: October 2009
  Purpose

Study Design: Adjuvant gemcitabine therapy has been shown to improve recurrence-free survival in pancreatic cancer underwent curative intent resection. This study is to evaluate whether combining concurrent chemo-radiotherapy can further improve the recurrence-free survival benefit of adjuvant gemcitabine chemotherapy in pancreatic cancer underwent curative resection.

Research Objective and Study End Points

  1. Primary endpoint: The primary end point is disease free survival.
  2. Secondary endpoints: The secondary end points are to evaluate the overall survival, local and distant recurrence rate, and impact on quality of life after adjuvant gemcitabine with or without CCRT in curatively resected pancreatic cancer.

Furthermore, the clinical, pathological and molecular prognostic factors in curatively resected pancreatic cancers will be evaluated.


Condition Phase
Pancreatic Cancer
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Randomized Phase III Study of Adjuvant Gemcitabine Versus Gemcitabine Plus Concurrent Chemoradiation in Pancreatic Cancer Underwent Curative Intent (R0 / R1) Resection

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The primary end-point is recurrence-free survival. [ Time Frame: Pancreatic Cancer Disease Committee ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The secondary end-points are overall survival; local and distant control rate, and the quality of life. [ Time Frame: Pancreatic Cancer Disease Committee ] [ Designated as safety issue: Yes ]

Enrollment: 265
Study Start Date: February 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
pancreatic cancer
resected pancreatic cancer

Detailed Description:

Treatment plan and Randomization scheme::

Patients will be randomized after stratification according to pathology report on section margin, tumor size, lymph node metastasis:

Patients who are randomized to Arm 1 will receive adjuvant chemotherapy started within 4-8 weeks after the surgery, and administered at D1, D8 and D15 every 4 weeks for 6 cycles (6 months). Patients who are allocated to Arm 2 will receive sandwich treatment, which comprised of the same adjuvant chemotherapy within 4-8 weeks after the surgery for 3 cycles (3 months), followed by CCRT (start 4-6 weeks after the last dose of 3rd cycle chemotherapy) and then another 3 cycles of gemcitabine monotherapy.

Statistical Consideration:

We anticipate the 2-year disease free survival will increase from 25% to 40% with the incorporation of CCRT into the adjuvant treatment for post-operative pancreatic adenocarcinoma. With a significant level of 0.05, 107 patients will be required for each treatment arm to reach 80% statistical power. Since the drop out rate is approximately 10%, 265 patients will be enrolled to ensure that we will have 214 (107x2) eligible patients in this study. We anticipate that we will recruit roughly 67 patients per year, therefore, patient recruitment will be completed in 4 years.

Randomization scheme:

Histo-/cyto-logically confirmed macroscopic complete resected pancreatic adenocarcinoma

  1. The primary end-point is disease free survival.
  2. The secondary end-points are overall survival; local and distant control rate, and the quality of life.
  3. The clinical and molecular prognostic factors for overall survival.

    • Radiation fields encompass initial main tumor of pancreas only with a safe margin of 1cm. Lymph node regions initially involved with tumor confirmed by excision will be included in the clinical target volume. Elective radiation to uninvolved lymph nodes will not be given.
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

We anticipate the 2-year disease free survival will increase from 25% to 40% with the incorporation of CCRT into the adjuvant treatment for post-operative pancreatic andenocarcinoma. With a significant level of 0.05,107 patients will be required for each treatment arm to reach 80% statistical power. Since the drop out rate is approximately 10%, 265 patients will be enrolled to ensure that we will have 214(107x2) eligible patients in this study. We anticipate that we will recruit roughly 67 patients per year, therefore, patient recruitment will be completed in 4 years.

Criteria

A.Eligibility Criteria

  1. Patients with pancreatic cancer after curative intent resection.
  2. The histology of resected tumor has to be adenocarcinoma.
  3. Age 20-75 years.
  4. ECOG performance scale 0-1.
  5. Patients must have normal organ and marrow function as defined below.
  6. The effects of study agents on the developing human fetus at the recommended therapeutic dose are unknown.
  7. to sign a written informed consent.
  8. Registered within 6 weeks after surgery.
  9. Preoperative abdominal CT or MRI with contrast enhancement.

B.Exclusion Criteria

  1. Patients with gross residual, macroscopic positive resection margin or distant metastases.
  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.
  5. Patients who had non-curable second primary malignancy.
  6. Uncontrolled intercurrent illness including.
  7. Pregnant women.
  8. receiving immuno-suppressive therapy、anti-coagulants.
  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: NCT00994721

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Mackay Memorial Hospital
Taipei, Taiwan
Chang-Gung Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Chang Gung Memorial Hospital
Taipei Veterans General Hospital, Taiwan
Mackay Memorial Hospital
Taichung Veterans General Hospital
National Cheng-Kung University Hospital
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University
Investigators
Study Chair: Tsann-Long Hwang, M.D. Chang Gung Memorial Hospital
Principal Investigator: Yu-Wen Tien Tien, Ph.D. National Taiwan University Hospital
Principal Investigator: Yi-Ming Shyr, M.D. Taipei Veterans General Hospital, Taiwan
Principal Investigator: Pin-Wen Lin, M.D National Cheng-Kung University Hospital
Principal Investigator: Yu-Lin Lin, M.D. National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Health Research Instiutes, Taiwan, National Institute of Cancer Research
ClinicalTrials.gov Identifier: NCT00994721     History of Changes
Other Study ID Numbers: T3207
Study First Received: March 26, 2008
Last Updated: October 11, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014