NCT00677144

Brief Summary

The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (OS) and Oxaliplatin and Capecitabine (XELOX) in patients with advance or recurrent colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 5, 2012

Status Verified

October 1, 2012

Enrollment Period

4 years

First QC Date

May 7, 2008

Last Update Submit

October 4, 2012

Conditions

Colorectal Neoplasm

Keywords

Colorectal NeoplasmS-1CapecitabineOxaliplatin

Outcome Measures

Primary Outcomes (1)

  • overall response rate

    4 years

Secondary Outcomes (1)

  • Safety, time to progression, and overall survival

    4.6 years

Study Arms (2)

OS (oxalipaltin+S-1)

EXPERIMENTAL

OS (oxaliplatin + S-1): Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days

Drug: OS (oxalipaltin+S-1)

XELOX (oxalipaltin+capecitabine)

ACTIVE COMPARATOR

XELOX (oxalipaltin+capecitabine): Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days

Drug: XELOX (oxalipaltin+capecitabine)

Interventions

OS (oxalipaltin+S-1)DRUG

Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO \[BSA \<1.25 40mg bid (total 80mg/day); BSA ≥1.25 - \<1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)\], divided by two on D1-14 every 21 days

Also known as: Eloxatin, TS-1
OS (oxalipaltin+S-1)
XELOX (oxalipaltin+capecitabine)DRUG

Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days

Also known as: Eloxatin, Xeloda
XELOX (oxalipaltin+capecitabine)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred
  • Unresectable, locally advanced or metastatic
  • At least one uni-dimensional measurable lesion by RECIST criteria
  • Age 18 to 75 years old
  • Estimated life expectancy ≥3 months
  • ECOG performance status ≤2
  • Adequate bone marrow function (WBCs ≥ 4,000/µL or absolute neutrophil count ≥ 1,500/µL, platelets ≥ 100,000/µL)
  • Adequate kidney function (creatinine \< 1.5 mg/dL)
  • Adequate liver function (bilirubin \< 2.0 mg/dL, transaminase levels \<2.5 times the upper normal limit)
  • Written informed consent

You may not qualify if:

  • Other tumor type than adenocarcinoma
  • Previous history of chemotherapy (exception : neoadjuvant or adjuvant chemotherapy without oxaliplatin)
  • Presence of CNS metastasis, psychosis, or seizure
  • Obvious bowel obstruction
  • Evidence of serious gastrointestinal bleeding
  • Past or concurrent history of neoplasm other than colorectal adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri
  • Pregnant or lactating women, women of childbearing potential not employing adequate contraception
  • Other serious illness or medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Medical Center

Anyang, 431-070, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Oxaliplatintitanium silicideXELOXCapecitabine

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

  • Dae Young Zang, MD, PhD

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 13, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 5, 2012

Record last verified: 2012-10

Locations

KR(1)