SOX Versus XELOX for Patients With Peritoneal Metastasis of Colorectal Cancer

August 17, 2016 updated by: The First People's Hospital of Changzhou

A Randomized Phase II Study of Oxaliplatin and S-1 (SOX) Versus Oxaliplatin and Capecitabine (XELOX) in Patients With Peritoneal Metastasis of Colorectal Cancer

The aim of this study is to compare the activity and safety of Oxaliplatin and S-1 (SOX) and Oxaliplatin and Capecitabine (XELOX) in patients with peritoneal metastasis of colorectal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Peritoneal dissemination from colorectal cancer is common, and it has been traditionally regarded as end-stage disease only amenable to palliation by systemic chemotherapy (sCT), or supportive care .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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Recruiting
        • The First People's Hospital of Changzhou
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically confirmed colorectal adenocarcinoma, initially diagnosed or recurred

Peritoneal metastasis of colorectal cancer

At least one uni-dimensional measurable lesion by RECIST criteria

Age 18 to 80 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOX(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
Drug: SOX
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
Other Names:
  • Eloxatin
  • TS-1
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
Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
Other Names:
  • Xeloda
  • Eloxatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate
Time Frame: 6 weeks
According to the RECIST criterion
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side-effect
Time Frame: 8 weeks
Safety was evaluated according to the NCI-CTC
8 weeks
Time to Progression
Time Frame: 6 years
According to the RECIST criterion
6 years
Overall Survival
Time Frame: 6 years
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First People's Hospital of Changzhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

June 1, 2019

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (Estimate)

August 17, 2016

Study Record Updates

Last Update Posted (Estimate)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZYY-CRC-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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