Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
TOX
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 14, 2012
CompletedFirst Posted
Study publicly available on registry
August 24, 2012
CompletedMarch 20, 2014
March 1, 2014
2.7 years
August 14, 2012
March 18, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Participants are assessed after 4 chemotherapy courses 3 weeks apart, an expected period of 12 weeks from starting the study treatment protocol.
Secondary Outcomes (1)
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.
Study Arms (1)
Pathological Response
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Any metastatic disease, T1, T2, N0
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Milad Hospitallead
Study Sites (1)
Fayyazbakhsh hospital
Tehran, Tehran Province, Iran
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bahram Salmanian, M.D.
Milad Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Clinical Research Center
Study Record Dates
First Submitted
August 14, 2012
First Posted
August 24, 2012
Study Start
June 1, 2008
Primary Completion
March 1, 2011
Last Updated
March 20, 2014
Record last verified: 2014-03