Trial | NCT01672333  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
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.
Study Started
Jun 30
2008
Primary Completion
Mar 31
2011
Last Update
Mar 20
2014
Estimate

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

Pathological Response Experimental

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
No Results Posted