Observational Study of Perioperative Chemotherapy in Gastric Cancer (PRECISO)

April 21, 2020 updated by: Grupo Oncologico Cooperativo Chileno de Investigation

Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • RM
      • Santiago, RM, Chile, 8380455
        • Instituto Nacional del Cancer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Current diagnosis of T3-4 and/or N+ M0 (according to staging system of the American Joint Committee on Cancer 2002) resectable gastric cancer. The resectability has to be confirmed by a surgical oncologist and/or Oncological Committee.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of adverse events
Time Frame: through study completion, an average of 6 months
Rate and description of adverse events
through study completion, an average of 6 months
Clinical response after three cycles of preoperative ECX
Time Frame: through study completion, an average of 6 months
Clinical response based on RECIST criteria
through study completion, an average of 6 months
To evaluate the surgical morbidity after three cycles of preoperative CT
Time Frame: through study completion, an average of 1 year
Hospital stay duration
through study completion, an average of 1 year
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
through study completion, an average of 1 year
progression free survival
Time Frame: through study completion, an average of 2 years
To evaluate the 3 year progression free survival
through study completion, an average of 2 years
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
through study completion, an average of 3 years
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
through study completion, an average of 1 year
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
through study completion, an average of 2 years
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
through study completion, an average of 2 years
HER 2 expression
Time Frame: through study completion, an average of 1 year
To determine the number of patients with HER2 overexpressing gastric cancers
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Oncologico Cooperativo Chileno de Investigation

Investigators

  • Principal Investigator: Bettina G Muller, MD, Grupo Oncologico Cooperativo Chileno de Investigation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2010

Primary Completion (ACTUAL)

March 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

June 30, 2012

First Submitted That Met QC Criteria

June 30, 2012

First Posted (ESTIMATE)

July 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOCCHI 2009-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD are planned to be shared once the final results have been published, foreseen for 2018, data include all datapoints incorporated in the anonymized data base. The investigators who wish to use the data should submit the protocol (approved by an IRB) and the request to access the database to GOCCHI (admin@gocchi.org)

IPD Sharing Time Frame

December 2019, for 10 years

IPD Sharing Access Criteria

The investigators who wish to use the data should submit the protocol (approved by an IRB) and the request to access the database to GOCCHI (admin@gocchi.org)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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