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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02072317

Enrollment

140

Registered

2014-02-26

Start date

2013-11-30

Completion date

2016-03-31

Last updated

2014-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Gastric Cancer

Keywords

PFS

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

Interventions

DRUGtaxel plus raltitrexed

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

DRUGtaxol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	Since the date of random to disease progression or any cause of death，the average time is 2 years

Countries

China

Contacts

Primary ContactGUO WEI JIAN, doctor

guoweijian1@hotmail.com13816066360

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026