Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma (TOX)
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ClinicalTrials.gov Identifier: NCT01672333 |
Recruitment Status :
Completed
First Posted : August 24, 2012
Last Update Posted : March 20, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Gastric Cancer | Drug: TOX | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
Allocation: | N/A |
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 |

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 |
- 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.
- 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.

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672333
Iran, Islamic Republic of | |
Fayyazbakhsh hospital | |
Tehran, Iran, Islamic Republic of |
Principal Investigator: | Bahram Salmanian, M.D. | Milad Hospital |
Responsible Party: | Dr Seyed-Hossein Yahyazadeh-Jabari, Director of Clinical Research Center, Milad Hospital |
ClinicalTrials.gov Identifier: | NCT01672333 |
Other Study ID Numbers: |
TOX protocol |
First Posted: | August 24, 2012 Key Record Dates |
Last Update Posted: | March 20, 2014 |
Last Verified: | March 2014 |
Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |