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

Last updated: May 17, 2019
Sponsor: Samsung Medical Center
Overall Status: Active - Not Recruiting

Phase

3

Condition

Colon Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT01092481
2009-11-008
2009-11-008
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 1580
Study Start date:
January 26, 2010
Estimated Completion Date:
December 31, 2019

Study 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.

Connect with a study center

  • Hallym University Medical Center

    Anyang, Gyeonggi 431-070
    Korea, Republic of

    Site Not Available

  • Soon Chun Hyang University Hospital Bucheon

    Bucheon, Gyeonggi 420-767
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang, Gyeonggi 410-768
    Korea, Republic of

    Site Not Available

  • School of Medicine, CHA University

    Seongnam, Gyeonggi 463-712
    Korea, Republic of

    Site Not Available

  • Sungkyunkwan University Masan Samsung Hospital

    Masan, Gyeongsangnam 630-522
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam 626-770
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun, Jeollanam 519-809
    Korea, Republic of

    Site Not Available

  • Dong-A University Medical Center

    Busan, 602-715
    Korea, Republic of

    Site Not Available

  • Kosin Medical Center

    Busan, 602-702
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Hospital

    Incheon, 405-760
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Site Not Available

  • Chung-Ang University College of Medicine

    Seoul, 156-755
    Korea, Republic of

    Site Not Available

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 135-710
    Korea, Republic of

    Site Not Available

  • Seoul St. Mary's hospital, Catholic Univerisity

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

  • Soonchunhyang University Hospital

    Seoul, 140-210
    Korea, Republic of

    Site Not Available

  • Yonsei University College of Medicine

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

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