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Comparison Between XELOX and S1, Oxaliplatin and Docetaxel as Neoadjuvant Chemotherapy for Gastric Cancer

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ClinicalTrials.gov Identifier: NCT02623153
Recruitment Status : Not yet recruiting
First Posted : December 7, 2015
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Tianshu Liu, Shanghai Zhongshan Hospital

Brief Summary:
The choice of neoadjuvant chemotherapy regimen for locally advanced gastric cancer is controversial. The aim of this study was to compare the short- and long-term outcomes of XELOX regimen with Docetaxel, S1 and oxaliplatin regimen as neoadjuvant chemotherapy regimen for locally advanced gastric cancer. The objective of this study is to determine what kind of neoadjuvant chemotherapy strategy can make subsequent radical surgery feasible and improve overall survival in patients with locally advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Oxaliplatin Drug: capecitabine Drug: S1 Drug: Docetaxel Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Comparison Between XELOX (Capecitabine and Oxaliplatin) and Docetaxel, Oxaliplatin and S1 Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: capecitabine and oxaliplatin
capecitabine of 1000 mg/m2, orally administered twice a day on days 1-14 and oxaliplatin at 130 mg/m2on day 1, as intravenous 2 h infusion
Drug: Oxaliplatin
oxaliplatin 130 mg/m2
Other Name: Eloxatin

Drug: capecitabine
capecitabine of 1000 mg/m2
Other Name: Xeloda

Experimental: S1, oxaliplatin and docetaxel
S1 of 40 mg/m2, orally administered twice a day on days 1-14,oxaliplatin 130 mg/m2 and docetaxel 40 mg/m2on day 1 as intravenous
Drug: Oxaliplatin
oxaliplatin 130 mg/m2
Other Name: Eloxatin

Drug: S1
S1 of 40 mg/m2
Other Name: tegafur

Drug: Docetaxel
docetaxel 40 mg/m2
Other Name: Taxotere




Primary Outcome Measures :
  1. response rate [ Time Frame: through study completion, an average of 24 weeks ]

Secondary Outcome Measures :
  1. R0 resection rate [ Time Frame: through study completion, an average of 24 weeks ]
  2. progression-free survival [ Time Frame: through study completion, an average of 1 year ]
  3. overall survival [ Time Frame: through study completion, an average of 2 year ]
  4. adverse events [ Time Frame: through study completion, an average of 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with unresectable, histologically confirmed gastric adenocarcinoma with no distant metastases were eligible for the study.

Exclusion Criteria:

  • peritoneal metastasis confirmed by CT scan
  • lung metastasis, liver metastasis, pleural effusion, and/or other distant metastasis
  • serious uncontrolled co-morbid conditions
  • lacking of measurable target lesion
  • any local intervention after initial diagnosis, such as surgical procedures, radiotherapy or trans-artery chemo-embolization
  • patients who could not comprehend or comply with the study were also ineligible.

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Responsible Party: Tianshu Liu, Chairman of the department of oncology, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02623153     History of Changes
Other Study ID Numbers: zswy003
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015
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
Docetaxel
Capecitabine
Oxaliplatin
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites