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
18 Years
70 Years
Both
Gastric Cancer
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Pathologic Response rate
Outcome 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.
Outcome Time Frame:
Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol.
Safety Issue:
No
Authority:
Iran: Ministry of Health
Study ID:
TOX protocol
NCT ID:
NCT01672333
Start Date:
June 2008
Completion Date:
Related Keywords:
- Gastric Cancer
- Adenocarcinoma
- Adenocarcinoma, Mucinous
- Stomach Neoplasms
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