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

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ClinicalTrials.gov Identifier: NCT02072317
Recruitment Status : Unknown
Verified February 2014 by Weijian Guo, Fudan University.
Recruitment status was:  Recruiting
First Posted : February 26, 2014
Last Update Posted : February 26, 2014
Sponsor:
Information provided by (Responsible Party):
Weijian Guo, Fudan University

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
Advanced Gastric Cancer Drug: taxel plus raltitrexed Drug: taxol Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2013
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel

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




Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072317


Contacts
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Contact: GUO WEI JIAN, doctor 13816066360 guoweijian1@hotmail.com

Locations
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China, Shanghai
Cancer hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: GUO WEI JIAN, doctor    13816066360    guoweijian1@hotmail.com   
Sponsors and Collaborators
Fudan University

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Responsible Party: Weijian Guo, attending, Fudan University
ClinicalTrials.gov Identifier: NCT02072317     History of Changes
Other Study ID Numbers: guoweijian-2013-raltitrexed
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: February 26, 2014
Last Verified: February 2014

Keywords provided by Weijian Guo, Fudan University:
PFS

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Raltitrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Folic Acid Antagonists
Enzyme Inhibitors