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

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: TOX

• Registration Number: NCT01672333
• Lead Sponsor: Milad Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2011-03
• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-21
• Study First Posted: 2012-08-24
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-18
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pathological Response	TOX	-

Primary Outcome Measures

Name	Time	Method
Pathologic Response rate	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

Name	Time	Method
clinical Response rate	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.

Trial Locations

Locations (1)

Fayyazbakhsh hospital; 🇮🇷 Tehran, Iran, Islamic Republic of