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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Gastric Cancer	Drug: TOX	Phase 2

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	50 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	June 2008
Actual Primary Completion Date :	March 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Pathological Response	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

Outcome Measures

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Primary Outcome Measures :

1. Pathologic Response rate [ Time Frame: 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 :

1. clinical Response rate [ Time Frame: 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Iran, Islamic Republic of
Fayyazbakhsh hospital
Tehran, Iran, Islamic Republic of

Sponsors and Collaborators

Milad Hospital

Investigators

Principal Investigator:	Bahram Salmanian, M.D.	Milad Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr Seyed-Hossein Yahyazadeh-Jabari, Director of Clinical Research Center, Milad Hospital
ClinicalTrials.gov Identifier:	NCT01672333 History of Changes
Other Study ID Numbers:	TOX protocol
First Posted:	August 24, 2012
Last Update Posted:	March 20, 2014
Last Verified:	March 2014

Additional relevant MeSH terms:

Adenocarcinoma; Stomach Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms	Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Oxaliplatin; Antineoplastic Agents