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

NCT ID: NCT01836120

Last Updated: 2013-04-19

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Raltitrexed plus Docetaxel

Group Type EXPERIMENTAL

Raltitrexed plus Docetaxel

Intervention Type DRUG

Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d

1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)

Docetaxel

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Raltitrexed plus Docetaxel

Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d

1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)

Intervention Type DRUG

Docetaxel

Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Signed informed consent form
2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
3. Histologically or cytologically confirmed gastric cancer;
4. The first-line chemotherapy failure (required containing 5-fluorouracil)
5. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
6. Life expectancy of at least 3 months;

Exclusion Criteria

1. Received any prior treatment including Raltitrexed;
2. Active or uncontrolled infection;
3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
4. Pregnant or lactating women.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hebei Tumor Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hebei Tumor Hospital

Shijiazhuang, Hebei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HBTH103

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.