Suspended

A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer

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What is being tested

Raltitrexed plus Docetaxel

+ Docetaxel

Drug
Who is being recruted

Digestive System Diseases+5

+ Digestive System Neoplasms

+ Gastrointestinal Diseases

From 18 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorHebei Tumor Hospital
Last updated: April 19, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.

NCT01836120
Principal SponsorHebei Tumor Hospital
Last updated: April 19, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDigestive System NeoplasmsGastrointestinal DiseasesGastrointestinal NeoplasmsNeoplasmsNeoplasms by SiteStomach DiseasesStomach Neoplasms

Criteria

6 inclusion criteria required to participate
At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
Histologically or cytologically confirmed gastric cancer
Life expectancy of at least 3 months
Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2
Show More Criteria
4 exclusion criteria prevent from participating
Active or uncontrolled infection
Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial
Pregnant or lactating women
Received any prior treatment including Raltitrexed

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hebei Tumor Hospital

Shijiazhuang, ChinaOpen Hebei Tumor Hospital in Google Maps
SuspendedOne Study Center