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Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma (TOX)

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ClinicalTrials.gov Identifier: NCT01672333
Recruitment Status : Completed
First Posted : August 24, 2012
Last Update Posted : March 20, 2014
Sponsor:
Information provided by (Responsible Party):
Dr Seyed-Hossein Yahyazadeh-Jabari, Milad Hospital

Study Description
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Brief Summary:
Early stage diagnosis of gastric cancer has ensued different approaches in its resection strategies. In order to increase the proportion of cases that undergo radical resection and reduce the recurrence rate, different pre-operative treatments are introduced. Here, the investigators investigate an active preoperative chemotherapeutic regimen to in patients with locally advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: TOX Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Response Rate and Side Effects of Preoperative Chemotherapy With Docetaxel, Oxaliplatin and Capcitabine (TOX) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
Study Start Date : June 2008
Actual Primary Completion Date : March 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Pathological Response Drug: TOX
oxaliplatin 100mg/m2 IV over 2 hours at 1st day docetaxel 50 mg/m2 IV over 1 hour at 1st day capecitabine 625 mg/m2 PO for 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Pathologic Response rate [ Time Frame: Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol. ]
    A single expert pathologist evaluates the pathologic outcome of the chemotherapy regimen after the completion of courses. Participants are divided into 3 groups including complete pathologic response, partial pathologic response and pathologic stable disease.


Secondary Outcome Measures :
  1. clinical Response rate [ Time Frame: Participants are assessed after 2 courses of Chemotherapy 3 weeks apart, an expected period of 6 weeks from starting the study treatment protocol. ]
    A single expert clinician evaluates the clinical outcome of the chemotherapy regimen after 2 primary courses 3 weeks apart. Evaluation is done with regards to the "TNM" scoring of gastric cancer (T for the size and expansion of the tumor, N for lymph node involvement, M for distant metastasis). Participants are divided into 4 groups including clinically progressive disease, complete clinical response, partial clinical response and clinically stable disease.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Tissue diagnosis of gastric or gastroesophageaql junction Adenocarcinoma
  • T3, T4 any N with non metastatic condition
  • Age 18 - 70 years
  • Performance status 0,1 according to ECOG criteria
  • Adequate bone marrow , liver and renal function
  • Hemoglobin ≥ 11 g/dl
  • Platelets ≥ 100000 / mm3
  • Absolute Neutrophil Count ≥ 1500/mm3
  • Normal Bilirubin
  • Normal Transaminases
  • Normal creatinin
  • Absence of active co-morbid illness (uncontrolled infection, uncontrolled DM, cardiopulmonary disease)

Exclusion Criteria:

  • Any metastatic disease, T1, T2, N0
Contacts and Locations
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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): NCT01672333


Locations
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Iran, Islamic Republic of
Fayyazbakhsh hospital
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Milad Hospital
Investigators
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Principal Investigator: Bahram Salmanian, M.D. Milad Hospital
More Information
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Responsible Party: Dr Seyed-Hossein Yahyazadeh-Jabari, Director of Clinical Research Center, Milad Hospital
ClinicalTrials.gov Identifier: NCT01672333    
Other Study ID Numbers: TOX protocol
First Posted: August 24, 2012    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms