Clincosm LogoSign in Get a demo

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

Sponsor
Fudan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02072317
Collaborator
(none)
140
Enrollment
1
Location
2
Arms
28
Duration (Months)
5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric Cancer Stage II Randomized Controlled Clinical Studies
Study Start Date :
Nov 1, 2013
Anticipated Primary Completion Date :
Mar 1, 2016
Anticipated Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Paclitaxel plus raltitrexed

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

Drug: taxel plus raltitrexed
taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle
Active Comparator: taxol

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

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

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival (PFS) [Since the date of random to disease progression or any cause of death，the average time is 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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≥1.5109/L；PLT≥80109/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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cancer hospital Fudan University Shanghai Shanghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weijian Guo, attending, Fudan University
ClinicalTrials.gov Identifier:
NCT02072317
Other Study ID Numbers:
  • guoweijian-2013-raltitrexed
First Posted:
Feb 26, 2014
Last Update Posted:
Feb 26, 2014
Last Verified:
Feb 1, 2014
Keywords provided by Weijian Guo, attending, Fudan University
PFS
Additional relevant MeSH terms:
Stomach Neoplasms
Raltitrexed

Study Results

No Results Posted as of Feb 26, 2014