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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dr Seyed-Hossein Yahyazadeh-Jabari, Milad Hospital

ClinicalTrials.gov Identifier:

NCT01672333

First received: August 14, 2012

Last updated: March 18, 2014

Last verified: March 2014

History of Changes

Purpose

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	Intervention	Phase
Gastric Cancer	Drug: TOX	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Stomach Carcinoma

U.S. FDA Resources

Further study details as provided by Milad Hospital:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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:

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. ] [ Designated as safety issue: Yes ]
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.


Enrollment:	50
Study Start Date:	June 2008
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672333

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

No publications provided


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
Study First Received:	August 14, 2012
Last Updated:	March 18, 2014
Health Authority:	Iran: Ministry of Health

ClinicalTrials.gov processed this record on March 03, 2015

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