Observational Study of Perioperative Chemotherapy in Gastric Cancer (PRECISO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01633203|
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment|
|Gastric Cancer||Drug: epirubicin + cisplatin + capecitabine polychemotherapy|
Chile belongs to the countries with a high mortality rate due to gastric cancer, and this disease is the most frequent cause of cancer death in Chile. Despite of adequate surgery, survival rates are disappointing, with less than 60% of patients for all stages achieving to be alive at 5 years. This is due to the fact that frequently gastric cancer is diagnosed at an advanced stage. For locally advanced gastric cancer a multimodality treatment is recommended, with the alternatives of surgery followed by chemotherapy (asian approach), surgery followed by chemoradiation (US approach) and perioperative chemotherapy (european approach). These three strategies are valid standard treatment options and have shown to improve overall survival in stage IB to IVA gastric cancer.
Perioperative chemotherapy administered pre- and postoperatively, has shown to downstage the tumor, increase curative resection, progression free and overall survival.
For patients with potentially resectable gastric cancer staged T2 or higher or cN+, NCCN Guidelines recommend perioperative chemotherapy (category1). Chilean guidelines for gastric cancer state the alternative of perioperative chemotherapy, however this approach has not been used widely in public hospitals because lack of financial support.
Some gastric cancers overexpress HER2, and this subset of patients benefit from targeted therapy at an advanced stage. The proportions of patients with these molecular characteristics vary widely depending of the geographic area. The chilean population has been investigated in small series, but the incidence of HER2 positive gastric cancer is not known. We therefore plan to measure HER2 expression in all participating patients.
|Study Type :||Observational|
|Actual Enrollment :||61 participants|
|Official Title:||Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery|
|Actual Study Start Date :||August 2010|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||December 2018|
locally advanced gastric cancer
Patients with resectable, locally advanced cT3-4 and/or N+ gastric carcinoma treated with 3 perioperative epirubicin cisplatin capecitabine polychemotherapy
Drug: epirubicin + cisplatin + capecitabine polychemotherapy
EPIRUBICIN (LKM)at a dose of 50 mg/m2 over 15 minutes is administered every 21 days.
CISPLATIN (LKM) at a dose of 60 mg/m2 over 4 hours is administered every 21 days. Patients must receive standardized hydration per protocol.
CAPECITABINE (Xeloda®) at a dose of 625 mg/m2 BID (i.e. 1250 mg/m2/day) 30 minutes after meals from day 1 to day 21 of every cycle of chemotherapy.
Loperamide will be prescribed in case of diarrhea.
- Rate of downstaging [ Time Frame: through study completion, an average of 3 months ]To determine the rate of downstaging of locally advanced cT3-4 and/or N+ gastric carcinomas after 3 cycles of preoperative chemotherapy with ECX
- Rate of adverse events [ Time Frame: through study completion, an average of 6 months ]Rate and description of adverse events
- Clinical response after three cycles of preoperative ECX [ Time Frame: through study completion, an average of 6 months ]Clinical response based on RECIST criteria
- To evaluate the surgical morbidity after three cycles of preoperative CT [ Time Frame: through study completion, an average of 1 year ]Hospital stay duration
- To evaluate the surgical mortality after three cycles of preoperative CT [ Time Frame: through study completion, an average of 1 year ]30 days postoperative mortality rate
- progression free survival [ Time Frame: through study completion, an average of 2 years ]To evaluate the 3 year progression free survival
- overall survival [ Time Frame: through study completion, an average of 3 years ]To evaluate the 5 year overall survival (OS) of patients treated with perioperative CT
- compliance with the planned postoperative therapy [ Time Frame: through study completion, an average of 1 year ]To evaluate the rate of start and completion of postoperative treatment
- EORTC QLQ-C30 after neoadjuvant chemotherapy and surgery [ Time Frame: through study completion, an average of 2 years ]To evaluate quality of life through patient reported outcomes of patients treated with perioperative chemotherapy
- EORTC QLQ-STO 22 after neoadjuvant chemotherapy and surgery [ Time Frame: through study completion, an average of 2 years ]To evaluate patient reported specific symptoms of patients treated with perioperative chemotherapy
- HER 2 expression [ Time Frame: through study completion, an average of 1 year ]To determine the number of patients with HER2 overexpressing gastric cancers
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): NCT01633203
|Instituto Nacional del Cáncer|
|Santiago, RM, Chile, 8380455|
|Principal Investigator:||Bettina G Muller, MD||Grupo Oncologico Cooperativo Chileno de Investigation|