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Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer

Primary Purpose

Advanced Gastric Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

taxel plus raltitrexed

taxol

About this trial

This is an interventional treatment trial for Advanced Gastric Cancer focused on measuring PFS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.18~75 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

Exclusion Criteria:

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

Sites / Locations

Cancer hospital Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Paclitaxel plus raltitrexed

taxol

Arm Description

taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle

taxol 135 mg/m2, every three weeks for a cycle

Outcomes

Primary Outcome Measures

Progression-free survival (PFS)

Secondary Outcome Measures

Full Information

NCT ID

NCT02072317

First Posted

February 24, 2014

Last Updated

February 24, 2014

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02072317

Brief Title

Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer

Official Title

Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer Stage II Randomized Controlled Clinical Studies

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Unknown status

Study Start Date

November 2013 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

from the first cycle of treatment (day one) to two month after the last cycle

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Gastric Cancer

Keywords

PFS

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel plus raltitrexed

Arm Type

Experimental

Arm Description

taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle

Arm Title

taxol

Arm Type

Active Comparator

Arm Description

taxol 135 mg/m2, every three weeks for a cycle

Intervention Type

Drug

Intervention Name(s)

taxel plus raltitrexed

Intervention Description

taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle

Intervention Type

Drug

Intervention Name(s)

taxol

Intervention Description

taxol 135 mg/m2, every three weeks for a cycle

Primary Outcome Measure Information:

Title

Progression-free survival (PFS)

Time Frame

Since the date of random to disease progression or any cause of death，the average time is 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1.18~75 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

GUO WEI JIAN, doctor

Phone

13816066360

guoweijian1@hotmail.com

Facility Information:

Facility Name

Cancer hospital Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

GUO WEI JIAN, doctor

Phone

13816066360

guoweijian1@hotmail.com

12. IPD Sharing Statement

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Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer

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