NCT01836120

Brief Summary

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.

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
100

participants targeted

Target at P75+ for phase_2 gastric-cancer

Timeline
Completed

Started Apr 2013

Typical duration for phase_2 gastric-cancer

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

April 1, 2013

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

3.7 years

First QC Date

April 17, 2013

Last Update Submit

April 18, 2013

Conditions

Gastric Cancer

Keywords

second-line chemotherapyRaltitrexed

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival (PFS)

    1 years

Secondary Outcomes (2)

  • Objective Response Rate (ORR)

    1 year

  • Overall Survival (OS)

    1 year

Study Arms (2)

Raltitrexed plus Docetaxel

EXPERIMENTAL
Drug: Raltitrexed plus Docetaxel

Docetaxel

ACTIVE COMPARATOR
Drug: Docetaxel

Interventions

Raltitrexed plus DocetaxelDRUG

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

Raltitrexed plus Docetaxel
DocetaxelDRUG

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

Docetaxel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Received any prior treatment including Raltitrexed;
  • Active or uncontrolled infection;
  • Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hebei Tumor Hospital

Shijiazhuang, Hebei, 050011, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

raltitrexedDocetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2013

First Posted

April 19, 2013

Study Start

April 1, 2013

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

April 19, 2013

Record last verified: 2013-04

Locations

CN(1)