NCT00994721

Brief Summary

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. 1.Primary endpoint： The primary end point is disease free survival.
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
9 months until next milestone

First Posted

Study publicly available on registry

October 14, 2009

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 4, 2016

Status Verified

October 1, 2009

Enrollment Period

6.9 years

First QC Date

March 26, 2008

Last Update Submit

May 3, 2016

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • The primary end-point is recurrence-free survival.

    Pancreatic Cancer Disease Committee

Secondary Outcomes (1)

  • The secondary end-points are overall survival; local and distant control rate, and the quality of life.

    Pancreatic Cancer Disease Committee

Study Arms (1)

pancreatic cancer

resected pancreatic cancer

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may not qualify if:

  • Patients with gross residual, macroscopic positive resection margin or distant metastases.
  • Patients may not be receiving any other investigational agents.
  • Patients who have had prior chemotherapy or radiotherapy are not eligible.
  • History of allergic reactions.
  • Patients who had non-curable second primary malignancy.
  • Uncontrolled intercurrent illness including.
  • Pregnant women.
  • receiving immuno-suppressive therapy、anti-coagulants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chang-Gung Memorial Hospital

Taipei, Taiwan

Location

Mackay Memorial Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Chiu YF, Liu TW, Shan YS, Chen JS, Li CP, Ho CL, Hsieh RK, Hwang TL, Chen LT, Ch'ang HJ; Taiwan Cooperative Oncology Group pancreatic cancer study group. Carbohydrate Antigen 19-9 Response to Initial Adjuvant Chemotherapy Predicts Survival and Failure Pattern of Resected Pancreatic Adenocarcinoma but Not Which Patients Are Suited for Additional Adjuvant Chemoradiation Therapy: From a Prospective Randomized Study. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):74-86. doi: 10.1016/j.ijrobp.2023.02.061. Epub 2023 Apr 11.

    PMID: 37055279DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Tsann-Long Hwang, M.D.

    Chang Gung Memorial Hospital

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

October 14, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 4, 2016

Record last verified: 2009-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(3)