Back to resultsResponse Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma (TOX)
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
TOX
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility 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
Sites / Locations
- Fayyazbakhsh hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pathological Response
Arm Description
Outcomes
Primary Outcome Measures
Pathologic Response rate
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
clinical Response rate
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01672333
Brief Title
Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
Acronym
TOX
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 Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milad Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pathological Response
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TOX
Intervention Description
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
Primary Outcome Measure Information:
Title
Pathologic Response rate
Description
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.
Time Frame
Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol.
Secondary Outcome Measure Information:
Title
clinical Response rate
Description
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.
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahram Salmanian, M.D.
Organizational Affiliation
Milad Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fayyazbakhsh hospital
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
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