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

Milad Hospital

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: TOX

Study type: Interventional

Funder types: Other

Identifiers

NCT01672333

TOX protocol

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Pathological Response

Experimental group

Treatment:

Drug: TOX