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Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma (TOX)
This study has been completed.
Sponsor:
Milad Hospital
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
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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: 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 |
Resource links provided by NLM:
Further study details as provided by Dr Seyed-Hossein Yahyazadeh-Jabari, 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. ]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. ]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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01672333
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
| 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 |
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 |
ClinicalTrials.gov processed this record on September 21, 2017