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Oxaliplatin and S-1 (OS) Versus Oxaliplatin and Capecitabine (XELOX) for Advanced Colorectal Cancer

NCT ID: NCT00677144

Last Updated: 2012-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-04-30

Brief Summary

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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.

Detailed Description

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Oxaliplatin and oral fluoropyrimidines (capecitabine or S-1) are active agents for colorectal cancer. Recent a phase II trial of combination chemotherapy of oxaliplatin with S-1 (OS) and several phase II trial of combination chemotherapy of oxaliplatin with capecitabine (XELOX) demonstrated good activity and mild toxicity in advanced colorectal cancer. Oxaliplatin and S-1 or capecitabine have distinct mechanisms of action and no overlap of key toxicities. Furthermore, oxaliplatin and fluorouracil were shown to be highly synergistic, not only in preclinical models but also in subsequent clinical trials.

Conditions

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Colorectal Neoplasm

Keywords

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Colorectal Neoplasm S-1 Capecitabine Oxaliplatin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OS (oxalipaltin+S-1)

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

Group Type EXPERIMENTAL

OS (oxalipaltin+S-1)

Intervention Type 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

XELOX (oxalipaltin+capecitabine)

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

Group Type ACTIVE_COMPARATOR

XELOX (oxalipaltin+capecitabine)

Intervention Type 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

Interventions

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OS (oxalipaltin+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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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Eloxatin TS-1 Eloxatin Xeloda

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Hallym University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dae Young Zang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hallym University Medical Center

Locations

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Hallym University Medical Center

Anyang, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HMC-HO-GI-0712

Identifier Type: -

Identifier Source: org_study_id