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Trial Title:
Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer
NCT ID:
NCT02072317
Condition:
Advanced Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Raltitrexed
Conditions: Keywords:
PFS
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
taxel plus raltitrexed
Description:
taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle
Arm group label:
Paclitaxel plus raltitrexed
Intervention type:
Drug
Intervention name:
taxol
Description:
taxol 135 mg/m2, every three weeks for a cycle
Arm group label:
taxol
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
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer hospital Fudan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
GUO WEI JIAN, doctor
Phone:
13816066360
Email:
guoweijian1@hotmail.com
Start date:
November 2013
Completion date:
March 2016
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02072317
