Observational Study of Perioperative Chemotherapy in Gastric Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the efficacy and toxicity of perioperative chemotherapy with Epirubicin + Cisplatin + Capecitabine (ECX) in routine clinical practice in a network of public hospitals in Santiago, Chile.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preoperative Dose-dense Chemotherapy With Weekly Cisplatin, Epirubicin and Paclitaxel to Treat Patients With Locally Gastric Cancer

NCT01830270

Stomach Neoplasms Oesophageal Junction Cancer Lower Oesophagus Cancer

TERMINATED PHASE2

Peri-operative Chemotherapy With ECX or XP in the Treatment of Advanced Gastric Cancer

NCT01558947

Gastric Cancer

UNKNOWN PHASE2

A Feasibility Study to Evaluate Adjuvant Chemoradiotherapy for Gastric Cancer

NCT00123318

Gastric Cancer

COMPLETED PHASE3

Exploratory Study on the S-1 + Paclitaxel Chemotherapy for Unresectable Gastric Cancer

NCT01756183

Surgically-Created Resection Cavity Drug Safety

UNKNOWN PHASE2

Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer

NCT00420394

Stomach Neoplasms

UNKNOWN PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

locally advanced gastric cancer

Patients with resectable, locally advanced cT3-4 and/or N+ gastric carcinoma treated with 3 perioperative epirubicin cisplatin capecitabine polychemotherapy

epirubicin + cisplatin + capecitabine polychemotherapy

Intervention Type DRUG

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.

Antiemetic therapy:

* Dexamethasone 8 mg IV and Ondansetron (LKM) 8 mg IV o Granisetron (Kytril®) prior to chemotherapy
* Rescue Ondansetron (LKM) 8 mg IV will be given during 24-hour hospitalization in case of emesis
* Symptomatic antiemetic therapy with thiethylperazine will be prescribed.

Loperamide will be prescribed in case of diarrhea.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Antiemetic therapy:

* Dexamethasone 8 mg IV and Ondansetron (LKM) 8 mg IV o Granisetron (Kytril®) prior to chemotherapy
* Rescue Ondansetron (LKM) 8 mg IV will be given during 24-hour hospitalization in case of emesis
* Symptomatic antiemetic therapy with thiethylperazine will be prescribed.

Loperamide will be prescribed in case of diarrhea.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically proven invasive carcinoma
* Age \> 18 years.
* ECOG performance status 0 or 1.
* Hemoglobin \> 9 g/dL
* Absolute neutrophil count \> 1.5 x 109/L
* Platelet count \> 100 x 109/L
* Creatinine \< 1.5 ULN
* Creatinine clearance \> 60 mL/min
* Serum bilirubin \< 1.5 x ULN
* AST \< 2.5 x ULN
* Women of child bearing potential: must agree to use an effective contraceptive method.
* Signed informed consent.

Exclusion Criteria

* ECOG \> 2.
* Pre-existing diarrhea uncontrolled with supportive care.
* Inability to swallow Xeloda tablets.
* History of mild-to-moderate renal insufficiency (creatinine clearance \< 45 mL/min).
* Signs or symptoms of clinically significant hepatic dysfunction (bilirubin \> 1.5 ULN, FA \> 2.5 ULN, albumin \< 2,5 g/dL).
* Significant cardiac dysfunction (LVEF \< LLN)
* Presence of distant metastasis, including clinical signs of peritoneal carcinomatosis
* Symptomatic gastric retention or severe dysphagia with a caloric intake of \< 1500 kcal/day
* Histology of lymphoma, GIST or neuroendocrine tumor
* Pregnant or breast-feeding women. Female patients must be postmenopausal, surgically sterile or they must agree to use an effective method of contraception.
* Any medical conditions that, in the investigator's opinion, would impose excessive risk to the patient. Examples of such conditions include congestive heart failure of Class III or IV of the NYHA classification, infection requiring parental or oral treatment, any altered mental status or any psychiatric condition that would interfere with the understanding of the informed consent.

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No