NCT01608646

Brief Summary

In this study, the relationship between DPD and the effects of S-1 combined with oxaliplatin chemotherapy were investigated in 200 patients with gastrointestinal carcinoma.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 31, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

May 31, 2012

Status Verified

May 1, 2012

Enrollment Period

1.4 years

First QC Date

May 13, 2012

Last Update Submit

May 28, 2012

Conditions

Gastrointestinal Cancer

Keywords

S-1OxaliplatinDihydropyrimidine Dehydrogenase

Outcome Measures

Primary Outcomes (1)

  • Objective tumor response

    Tumor response was evaluated by RECIST 1.1. The relationship between DPD activity and the objective tumor response will be evaluated by Cox's proportional hazards regression model.

    Every eight weeks

Secondary Outcomes (3)

  • Overall survival

    Three year

  • Progress-free survival

    one year

  • Adverse event incidence

    One year

Study Arms (1)

S-1 plus oxaliplatin

NO INTERVENTION

S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.

Drug: S-1 plus oxaliplatin

Interventions

S-1 plus oxaliplatinDRUG

S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.

Also known as: TS-1 plus oxaliplatin, Teysuno plus oxaliplatin
S-1 plus oxaliplatin

Eligibility Criteria

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

You may qualify if:

  • Age ≧18;
  • Histologically or cytologically confirmed gastrointestinal cancer；
  • ECOG ≦2;
  • Physician's intention to treat with S-1 combined with platinum regimen on disease status and clinical judgment;
  • Life expectancy of at least three months;
  • Written informed consent to participate in the trial;

You may not qualify if:

  • History of severe hypersensitivity reactions to the ingredients of S-1 or oxaliplatin;
  • Inadequate hematopoietic function which is defined as below:
  • white blood cell (WBC) less than 3,500/mm\^3
  • absolute neutrophil count (ANC) less than 1,500/mm\^3
  • platelets less than 80,000/mm\^3
  • Inadequate hepatic or renal function which is defined as below:
  • serum bilirubin greater than 1.5 times the upper limit of normal range
  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
  • greater than 2.5 times the ULN if no demonstrable liver metastases or
  • greater than 5 times the ULN in the presence of liver metastases
  • blood creatinine level greater than 2 times ULN
  • Presence of peripheral neuropathy;
  • Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug;
  • Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male);
  • Psychiatric disorder or symptom that makes participation of the patient difficult;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing hospital of the fourth military medical univercity

Xijing, Shanxi, 710031, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

S 1 (combination)Oxaliplatintitanium silicidetegafur-gimeracil-oteracil

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Study Officials

  • WENCHAO LIU, professor

    xijing hospital of the fourth military medical univercity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

WENCHAO LIU, Professor

CONTACT

029-84775407liuch@FMMU.edu.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2012

First Posted

May 31, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2018

Last Updated

May 31, 2012

Record last verified: 2012-05

Locations

CN(1)