Response Rate and Side Effects of Preoperative Chemotherapy (TOX Regimen) in Patients With Locally Advanced Operable Gastric Adenocarcinoma
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.
|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|
- 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.
- 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.
|Study Start Date:||June 2008|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|Experimental: Pathological Response||
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672333
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Principal Investigator:||Bahram Salmanian, M.D.||Milad Hospital|