Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer
1 other identifier
interventional
140
1 country
1
Brief Summary
The purpose of this study is to evaluate and compare safety and effectiveness of Chemotherapy in Paclitaxel plus raltitrexed plug compare with taxol second-line treatment for advanced gastric cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2013
1 active site
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
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 24, 2014
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFebruary 26, 2014
February 1, 2014
2.3 years
February 24, 2014
February 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Since the date of random to disease progression or any cause of death，the average time is 2 years
Study Arms (2)
Paclitaxel plus raltitrexed
EXPERIMENTALtaxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle
taxol
ACTIVE COMPARATORtaxol 135 mg/m2, every three weeks for a cycle
Interventions
taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle
Eligibility Criteria
You may qualify if:
- \~75 years old 2.Pathological diagnosis of gastric cancer or gastroesophageal junction adenocarcinoma 3.patient failed after The first line treatment of 5-Fu and platinum ,patient relapse half year after using 5 - Fu and platinum as Postoperative adjuvant chemotherapy 4.ECOG 0-1 5.At least one measurable objective tumor lesions 6.ANC≥1.5\*109/L；PLT≥80\*109/L；HB≥90g/L；TBI≤1.5(UNL); ALT、AST≤1.5ULN； Cr≤ULN；Ccr≥60ml/min 7.Expected survival period for 3 months or more 8. patients with voluntary participation, and sign the informed consent
You may not qualify if:
- Recurrence after transfer have received taxol or docetaxel as first-line chemotherapy,If the adjuvant chemotherapy with paclitaxel,From the last chemotherapy for 6 months or less
- With uncontrollable large pleural or peritoneal effusion
- In the near future has a history of myocardial infarction (3 months)
- Malignant tumour of the past five years with other organizations to source, but the full treatment of cervical carcinoma in situ and except skin basal cell carcinoma and squamous cell carcinomas;
- With brain metastasis
- Severe uncontrolled medical disease or acute infection
- Pregnancy or breast-feeding women
- Has a long history of chronic diarrhea, or now complete intestinal obstruction patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Cancer hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- attending
Study Record Dates
First Submitted
February 24, 2014
First Posted
February 26, 2014
Study Start
November 1, 2013
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
February 26, 2014
Record last verified: 2014-02