Gastric Cancer
Conditions
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.
Interventions
DRUGTOX
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
Sponsors
Milad Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Response rate | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Iran
Outcome results
None listed