NCT00677443

Brief Summary

Primary objective : To compare the combination of S-1 and oxaliplatin(SOX) to the combination of capecitabine and oxaliplatin(COX) therapy for advanced or metastatic colorectal carcinoma. Secondary objectives :

  1. 1.To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.
  2. 2.To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
344

participants targeted

Target at P25-P50 for phase_3 colorectal-cancer

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_3 colorectal-cancer

Geographic Reach
1 country

11 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

May 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2008

Completed
18 days until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

May 12, 2008

Last Update Submit

June 12, 2013

Conditions

Colorectal Cancer

Keywords

metastatic colorectal cancerS-1CapecitabineOxaliplatinnon-inferiority study

Outcome Measures

Primary Outcomes (1)

  • To compare the combination of S-1 and oxaliplatin to the combination of capecitabine and oxaliplatin in terms of progression free survival in patients previously untreated by systemic therapy for advanced or metastatic colorectal carcinoma.

    9 months

Secondary Outcomes (2)

  • To evaluate and compare the efficacy (overall survival and response rate) in the two treatment groups.

    24 months

  • To evaluate and compare the quality of life of the patients and safety profiles of the two treatment groups.

    24 months

Study Arms (2)

S-1 and Oxaliplatin

EXPERIMENTAL

S-1 and Oxaliplatin S-1 : 80 mg/m2/day D1-14 Oxaliplatin : 130 mg/m2/day D1 Repeated every 3 weeks

Drug: S-1 & Oxaliplatin

Capecitabine and Oxaliplatin

ACTIVE COMPARATOR

Capecitabine and Oxaliplatin

Drug: Capecitabine & Oxaliplatin

Interventions

S-1 & OxaliplatinDRUG

S-1 and Oxaliplatin : S-1 80 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks

Also known as: S-1 and Oxaliplatin
S-1 and Oxaliplatin
Capecitabine & OxaliplatinDRUG

COX : Capecitabine 1000 mg/m2/day, D1-14 Oxaliplatin, 130 mg/m2/day, D1 Repeated every 3 weeks

Also known as: Capecitabine and Oxaliplatin
Capecitabine and Oxaliplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented colorectal adenocarcinoma
  • Age over 18 years old
  • Performance status (ECOG scale): 0-2
  • Measurable or evaluable disease
  • Patients can take food and drugs orally
  • Adequate organ functions
  • Life expectancy ≥ 3 months
  • Patients should sign a written informed consent before study entry

You may not qualify if:

  • Tumor type other than adenocarcinoma
  • Second primary malignancy
  • Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for advanced or metastatic colorectal cancer
  • Adjuvant or neo-adjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment.
  • Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization.
  • Presence of CNS metastasis
  • Obvious peritoneal seeding or bowel obstruction disturbing oral intake
  • Symptomatic peripheral neuropathy
  • Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery. The patient received curative operation or RFA for metastatic disease.
  • Serious illness or medical conditions
  • Receiving a concomitant treatment with drugs interacting with S-1, capecitabine or oxaliplatin, as follows;flucytosine, a fluorinated pyrimidine antifungal agent phenytoin warfarin etc.
  • Received any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment with study drug.
  • Pregnant or lactating woman
  • Women of child bearing potential not using a contraceptive method
  • Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Chonnam National University Hospital

Hwasun, Jeollanamdo, 519-809, South Korea

Location

Yeungnam University

Daegu, 705-717, South Korea

Location

Gachon University Gil Medical Center

Inchon, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea Cancer Center Hospital

Seoul, 139-706, South Korea

Location

Soon Chun Hyang University Hospital

Seoul, 140-743, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Yonsei University

Seoul, South Korea

Location

Related Publications (2)

  • Kim ST, Hong YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Lee JW, Jo SJ, Park YS. S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for the first-line treatment of patients with metastatic colorectal cancer: updated results from a phase 3 trial. BMC Cancer. 2014 Nov 26;14:883. doi: 10.1186/1471-2407-14-883.

    PMID: 25424120DERIVED

  • Hong YS, Park YS, Lim HY, Lee J, Kim TW, Kim KP, Kim SY, Baek JY, Kim JH, Lee KW, Chung IJ, Cho SH, Lee KH, Shin SJ, Kang HJ, Shin DB, Jo SJ, Lee JW. S-1 plus oxaliplatin versus capecitabine plus oxaliplatin for first-line treatment of patients with metastatic colorectal cancer: a randomised, non-inferiority phase 3 trial. Lancet Oncol. 2012 Nov;13(11):1125-32. doi: 10.1016/S1470-2045(12)70363-7. Epub 2012 Oct 10.

    PMID: 23062232DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

S 1 (combination)OxaliplatinXELOXCapecitabine

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Young Suk Park, M.D.,Ph.D.

    Samsung Medical Center, Seoul, Korea

    STUDY CHAIR

  • Hye Jin Kang, M.D.,Ph.D.

    Korea Cancer Center Hospital , Seoul, Korea

    PRINCIPAL INVESTIGATOR

  • Jee Hyun Kim, M.D.,Ph.D.

    Seoul National University Bundang Hospital, Gyeonggi, Korea

    PRINCIPAL INVESTIGATOR

  • Tae Won Kim, M.D.,Ph.D.

    Asan Medical Center, Seoul, Korea

    PRINCIPAL INVESTIGATOR

  • Tae-Yoo Kim, M.D.,Ph.D.

    Seoul National University Hospital , Seoul, Korea

    PRINCIPAL INVESTIGATOR

  • Dong Bok Shin, M.D.,Ph.D.

    Gil Medical Center, Gyeonggi, Korea

    PRINCIPAL INVESTIGATOR

  • Joong Bae Ahn, M.D.,Ph.D.

    Yonsei Medical Center, Severance Hospital, Seoul, Korea

    PRINCIPAL INVESTIGATOR

  • Kyung Hee Lee, M.D.,Ph.D.

    Yeungnam University College of Medicine , Daegu, Korea

    PRINCIPAL INVESTIGATOR

  • Namsu Lee, M.D.,Ph.D.

    Soon Chun Hyang University Hospital , Seoul, Korea

    PRINCIPAL INVESTIGATOR

  • Ik-Joo Chung, M.D.,Ph.D.

    Chonnam National University Hwasun Hospital, Jeollanamdo, Korea

    PRINCIPAL INVESTIGATOR

  • Yong Sang Hong, M.D.,Ph.D.

    National Cancer Center, Gyeonggi, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.,Ph.D. Professor

Study Record Dates

First Submitted

May 12, 2008

First Posted

May 14, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2009

Study Completion

January 1, 2011

Last Updated

June 14, 2013

Record last verified: 2013-06

Locations

KR(11)