Study Investigating the Role of Oxaliplatin Duration in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Colon Cancer Therapy

This study is currently recruiting participants.
Verified June 2013 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01092481
First received: November 22, 2009
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.


Condition Intervention Phase
Colon Cancer
Drug: oxaliplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study Investigating the Role of Oxaliplatin Duration (3 Months Versus 6 Months) in Modified FOLFOX-6 or CAPOX Regimen as Adjuvant Therapy for Patients With Stage II/III Colon Cancer

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • quality of life [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • safety profiles [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    Safety will be assessed on the basis of an analysis of adverse events, standard clinical chemistry and hematology findings. Clinical and laboratory toxicities/symptoms will be graded according to the CTCAE 3.0. Adverse events which are not reported in CTCAE 3.0 will be graded as mild, moderate, severe or life threatening.


Estimated Enrollment: 2660
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: FOLFOX_12 or CAPOX_8
6 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
Drug: oxaliplatin
to confirm that first 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.
Other Name: oxaliplatin (modified FOLFOX-6 OR CAPOX)
Experimental: FOLFOX_6 or CAPOX_4
3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX
Drug: oxaliplatin
to confirm that first 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.
Other Name: oxaliplatin (modified FOLFOX-6 OR CAPOX)

Detailed Description:

This study is designed to confirm that first 3 months of oxaliplatin in 6 months of modified FOLFOX-6 or CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer. In addition, we would like to characterize pharmacogenomic profile associated with toxicities and gene expression profiling to predict the recurrence of colon cancer as parallel study.

  Eligibility

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

Inclusion Criteria:

  • Curatively resected, histologically confirmed colon adenocarcinoma
  • AJCC/UICC high-risk stage II, stage III colon cancer
  • Age over 18 years old
  • Performance status (ECOG scale): 0-1
  • Adequate major organ functions
  • Patients should sign a written informed consent before study entry

Exclusion Criteria:

  • Colon cancer other than adenocarcinoma
  • Rectal cancer
  • R1 or R2 resections
  • Other malignancies within the last 5 years
  • Symptomatic peripheral sensory neuropathy
  • Presence of other serious disease
  • Lactating or pregnant women
  • Fertile women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092481

Contacts
Contact: Young Suk Park, M.D.,Ph.D. 82-2-3410-3459 pys27hmo@skku.edu

Locations
Korea, Republic of
Hallym University Medical Center Recruiting
Anyang, Gyeonggi, Korea, Republic of, 431-070
Contact: Dae Young Zang, M.D., Ph.D    82-31-380-3871    fhdzang@hallym.or.kr   
Principal Investigator: Dae Young Zang, M.D., Ph.D         
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Gyeonggi, Korea, Republic of, 420-767
Contact: Dae Sik Hong, M.D., Ph.D    82-32-621-5104    dshong@schbc.ac.kr   
Principal Investigator: Dae Sik Hong, M.D., Ph.D         
National Cancer Center Recruiting
Goyang, Gyeonggi, Korea, Republic of, 410-768
Contact: Sun Young Kim, M.D., Ph.D    82-31-920-1661    cathykimmd@gmail.com   
Principal Investigator: Sun Young Kim, M.D., Ph.D         
School of Medicine, CHA University Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-712
Contact: Doyeun Oh, M.D., Ph.D    82-31-780-5217    doh@cha.ac.kr   
Principal Investigator: Doyeun Oh, M.D., Ph.D         
Sungkyunkwan University Masan Samsung Hospital Recruiting
Masan, Gyeongsangnam, Korea, Republic of, 630-522
Contact: Kyung Tae Park, M.D., Ph.D    82-55-290-6007    pkt@unitel.co.kr   
Principal Investigator: Kyung Tae Park, M.D., Ph.D         
Pusan National University Yangsan Hospital Recruiting
Yangsan, Gyeongsangnam, Korea, Republic of, 626-770
Contact: Seong - Geun Kim, M.D., Ph.D    82-55-360-1424    patheny@nate.com   
Principal Investigator: Seong - Geun Kim, M.D., Ph.D         
Chonnam National University Hwasun Hospital Recruiting
Hwasun, Jeollanam, Korea, Republic of, 519-809
Contact: Ik Joo Chung, M.D., Ph.D    82-61-379-7632    ijchung@jnu.ac.kr   
Principal Investigator: Ik Joo Chung, M.D., Ph.D         
Kosin Medical Center Recruiting
Busan, Korea, Republic of, 602-702
Contact: Seong-Hoon Shin, M.D., Ph.D    82-51-990-6107    ssh1533@hanmail.net   
Principal Investigator: Seong-Hoon Shin, M.D., Ph.D         
Dong-A University Medical Center Recruiting
Busan, Korea, Republic of, 602-715
Contact: Hyuk-Chan Kwon, M.D., Ph.D    82-51-240-2887    hckwon@dau.ac.kr   
Principal Investigator: Hyuk-Chan Kwon, M.D., Ph.D         
Gachon University Gil Hospital Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Dong Bok Shin, M.D., Ph.D    82-32-460-2187    dbs@ghil.com   
Principal Investigator: Dong Bok Shin, M.D., Ph.D         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Tae Won Kim, M.D., Ph.D    82-2-3010-3210    twkimmd@amc.seoul.kr   
Principal Investigator: Tae Won Kim, M.D., Ph.D         
Seoul St. Mary's hospital, Catholic Univerisity Recruiting
Seoul, Korea, Republic of, 137-701
Contact: Myung Ah Lee, M.D., Ph.D    82-2-2258-6044    angelamd@catholic.ac.kr   
Principal Investigator: Myung Ah Lee, M.D., Ph.D         
Soonchunhyang University Hospital Recruiting
Seoul, Korea, Republic of, 140-210
Contact: Nam Su Lee, M.D., Ph.D    82-2-709-9287    mdnslee@hosp.sch.ac.kr   
Principal Investigator: Nam Su Lee, M.D., Ph.D         
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Contact: In Sil Choi, M.D., Ph.D    82-2-870-2231    hmoischoi@hanmail.net   
Principal Investigator: In Sil In Sil, M.D., Ph.D         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Young Suk Park, M.D.,Ph.D.    82-2-3410-3459    pys27hmo@skku.edu   
Sub-Investigator: Ho-Kyung Chun, M.D., Ph.D         
Sub-Investigator: Woo Yong Lee, M.D., Ph.D         
Sub-Investigator: Seong Hyeon Yun, M.D., Ph.D         
Sub-Investigator: Hee Cheol Kim, M.D., Ph.D         
Sub-Investigator: Yong Beom Cho, M.D.         
Sub-Investigator: Haeran Yun, M.D.         
Sub-Investigator: Won Ki Kang, M.D., Ph.D         
Sub-Investigator: Ho Yeong Lim, M.D., Ph.D         
Sub-Investigator: Joon Oh Park, M.D., Ph.D         
Sub-Investigator: Se Hoon Park, M.D., Ph.D         
Sub-Investigator: Jeeyun Lee, M.D., Ph.D         
Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Joong Bae Ahn, M.D., Ph.D    82-2-2228-8134    vvswm513@yuhs.ac   
Principal Investigator: Joong Bae Ahn, M.D., Ph.D         
Chung-Ang University College of Medicine Recruiting
Seoul, Korea, Republic of, 156-755
Contact: Joung Soon Jang, M.D., Ph.D    82-2-6299-1427    alsaba@hanmail.net   
Principal Investigator: Joung Soon Jang, M.D., Ph.D         
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Young Suk Park, M.D.,Ph.D. Samsung Medical Center, Seoul, Korea
  More Information

No publications provided

Responsible Party: Young Suk Park, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01092481     History of Changes
Other Study ID Numbers: 2009-11-008, 2009-11-008
Study First Received: November 22, 2009
Last Updated: June 12, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Adjuvant FOLFOX or CAPOX Therapy
Stage II/III Colon Cancer
Adjuvant Therapy

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014