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

NCT ID: NCT02072317

Last Updated: 2014-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2016-03-31

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

Conditions

Advanced Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel plus raltitrexed

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

Group Type: EXPERIMENTAL

taxel plus raltitrexed

Intervention Type: DRUG

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

taxol

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

Group Type: ACTIVE_COMPARATOR

taxol

Intervention Type: DRUG

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

Interventions

taxel plus raltitrexed

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

Intervention Type: DRUG

taxol

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

Intervention Type: DRUG

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

1. 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

2. With uncontrollable large pleural or peritoneal effusion

3. In the near future has a history of myocardial infarction (3 months)

4. 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;

5. With brain metastasis

6. Severe uncontrolled medical disease or acute infection

7. Pregnancy or breast-feeding women

8. Has a long history of chronic diarrhea, or now complete intestinal obstruction patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Weijian Guo

attending

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

GUO WEI JIAN, doctor

Role: CONTACT

guoweijian1@hotmail.com

13816066360

Facility Contacts

GUO WEI JIAN, doctor

Role: primary

guoweijian1@hotmail.com

13816066360

Other Identifiers

guoweijian-2013-raltitrexed

Identifier Type: -

Identifier Source: org_study_id