NCT01959061

Brief Summary

To evaluate the efficacy and safety of Raltitrexed for advanced colorectal cancer

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
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_4

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

September 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

4.3 years

First QC Date

September 18, 2013

Last Update Submit

March 9, 2017

Conditions

Colorectal Cancer Metastatic

Keywords

Advanced colorectal cancer of liver metastatic

Outcome Measures

Primary Outcomes (1)

  • Progression-free survivial

    From date of randomization until date of first documented PD, date of death

    8 months after last patient randomized

Study Arms (1)

Raltitrexed and Oxaliplatin

EXPERIMENTAL

Raltitrexed and Oxaliplatin were mixed with 10-15 ml lipiodol by arterial chemoembolization on day 1 and during each 28-day cycle.

Drug: RaltitrexedDrug: OxaliplatinDrug: lipiodol

Interventions

RaltitrexedDRUG

4mg, every 4 weeks,transhepatic arterial infusion

Raltitrexed and Oxaliplatin
OxaliplatinDRUG

100\~150mg, every 4 weeks, transhepatic arterial infusion

Raltitrexed and Oxaliplatin
lipiodolDRUG

5-20ml, every 4 weeks, hepatic artery embolization

Raltitrexed and Oxaliplatin

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed colorectal adenocarcinoma
  • Disease limited to the liver Unresectable disease by surgery or other local therapies
  • Age \>18 years
  • ECOG performance status 0-2,Child pugh A or B
  • Expected survival ≥ 3 months
  • Adequate hematological, hepatic, and renal function

You may not qualify if:

  • Pregnant or lactating women
  • Patients with severe organ dysfunction or failure
  • With severe cardiovascular disease, or mental
  • Extraliver metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 2000032, China

RECRUITING

MeSH Terms

Interventions

raltitrexedOxaliplatinEthiodized Oil

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsIodized OilPlant OilsOilsLipidsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Jianhua Wang

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianhua Wang

CONTACT

021-64041990wang.jianhua@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2013

First Posted

October 9, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 13, 2017

Record last verified: 2017-03

Locations

CN(1)