Gastric CancerPRECISONCT01633203
Observational Study of Perioperative Chemotherapy in Gastric Cancer
An observational study of Gastric Cancer, run by Grupo Oncologico Cooperativo Chileno de Investigation at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- epirubicin + cisplatin + capecitabine polychemotherapy
- Type of treatment
- Injection or infusion
- How many people
- 61 participants
- Where
- 1 siteChile
- Study dates
- Aug 2010to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- epirubicin + cisplatin + capecitabine polychemotherapy
- Keywords
- gastric cancer, combination chemotherapy, HER-2 gene, quality of life
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epirubicin + cisplatin + capecitabine polychemotherapyDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| locally advanced gastric cancer | Patients with resectable, locally advanced cT3-4 and/or N+ gastric carcinoma treated with 3 perioperative epirubicin cisplatin capecitabine polychemotherapy Receives: Drug: epirubicin + cisplatin + capecitabine polychemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of downstaging
To determine the rate of downstaging of locally advanced cT3-4 and/or N+ gastric carcinomas after 3 cycles of preoperative chemotherapy with ECX
Measured: through study completion, an average of 3 months
Secondary outcomes (10)
Rate of adverse events
Rate and description of adverse events
Measured: through study completion, an average of 6 months
Clinical response after three cycles of preoperative ECX
Clinical response based on RECIST criteria
Measured: through study completion, an average of 6 months
To evaluate the surgical morbidity after three cycles of preoperative CT
Hospital stay duration
Measured: through study completion, an average of 1 year
To evaluate the surgical mortality after three cycles of preoperative CT
30 days postoperative mortality rate
Measured: through study completion, an average of 1 year
progression free survival
To evaluate the 3 year progression free survival
Measured: through study completion, an average of 2 years
overall survival
To evaluate the 5 year overall survival (OS) of patients treated with perioperative CT
Measured: through study completion, an average of 3 years
compliance with the planned postoperative therapy
To evaluate the rate of start and completion of postoperative treatment
Measured: through study completion, an average of 1 year
EORTC QLQ-C30 after neoadjuvant chemotherapy and surgery
To evaluate quality of life through patient reported outcomes of patients treated with perioperative chemotherapy
Measured: through study completion, an average of 2 years
EORTC QLQ-STO 22 after neoadjuvant chemotherapy and surgery
To evaluate patient reported specific symptoms of patients treated with perioperative chemotherapy
Measured: through study completion, an average of 2 years
HER 2 expression
To determine the number of patients with HER2 overexpressing gastric cancers
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startAug 2010
- Primary completionMar 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Oncologico Cooperativo Chileno de Investigation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Bettina G Muller, MD, Principal investigator, Grupo Oncologico Cooperativo Chileno de Investigation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633203
- Sponsor's protocol ID
- GOCCHI 2009-01
- Acronym
- PRECISO
- Status last verified
- Mar 2019
- First submitted
- 30 Jun 2012
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Publications
Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
PubMed 16822992Okines AFC, Norman AR, McCloud P, Kang YK, Cunningham D. Meta-analysis of the REAL-2 and ML17032 trials: evaluating capecitabine-based combination chemotherapy and infused 5-fluorouracil-based combination chemotherapy for the treatment of advanced oesophago-gastric cancer. Ann Oncol. 2009 Sep;20(9):1529-1534. doi: 10.1093/annonc/mdp047. Epub 2009 May 27.
PubMed 19474114Garcia CC, Benavides CC, Apablaza SP, Rubilar PO, Covacevich SR, Penaloza PM, Guerra JC, Horwitz BZ, Domancic PH, Bustamante R M, Romero S C. [Surgical treatment of gastric cancer: results in 423 cases]. Rev Med Chil. 2007 Jun;135(6):687-95. Epub 2007 Aug 22. Spanish.
PubMed 17728893
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Patients With Locally Advanced Gastric Cancer Treated With Perioperative Chemotherapy and Surgery
- ClinicalTrials.gov ID
- NCT01633203
- Acronym / sponsor ID
- PRECISO / GOCCHI 2009-01
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, combination chemotherapy, HER-2 gene, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Grupo Oncologico Cooperativo Chileno de InvestigationResearch network
- Study start
- Aug 2010 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| locally advanced gastric cancer | – | Drug: epirubicin + cisplatin + capecitabine polychemotherapyPatients with resectable, locally advanced cT3-4 and/or N+ gastric carcinoma treated with 3 perioperative epirubicin cisplatin capecitabine polychemotherapy |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epirubicin + cisplatin + capecitabine polychemotherapyEPIRUBICIN (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. | Drug | locally advanced gastric cancer |
Primary outcome
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
10 secondary outcomes
Rate of adverse events
Time frame: 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
To evaluate the surgical morbidity after three cycles of preoperative CT
Time frame: 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
progression free survival
Time frame: through study completion, an average of 2 years
overall survival
Time frame: through study completion, an average of 3 years
compliance with the planned postoperative therapy
Time frame: 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
EORTC QLQ-STO 22 after neoadjuvant chemotherapy and surgery
Time frame: through study completion, an average of 2 years
HER 2 expression
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Background: PubMed 16822992Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
- Background: PubMed 19474114Okines AFC, Norman AR, McCloud P, Kang YK, Cunningham D. Meta-analysis of the REAL-2 and ML17032 trials: evaluating capecitabine-based combination chemotherapy and infused 5-fluorouracil-based combination chemotherapy for the treatment of advanced oesophago-gastric cancer. Ann Oncol. 2009 Sep;20(9):1529-1534. doi: 10.1093/annonc/mdp047. Epub 2009 May 27.
- Background: PubMed 17728893Garcia CC, Benavides CC, Apablaza SP, Rubilar PO, Covacevich SR, Penaloza PM, Guerra JC, Horwitz BZ, Domancic PH, Bustamante R M, Romero S C. [Surgical treatment of gastric cancer: results in 423 cases]. Rev Med Chil. 2007 Jun;135(6):687-95. Epub 2007 Aug 22. Spanish.
- Homepage of the Chilean Cooperative Group for Oncological ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bettina G Muller, MD principal investigator
Grupo Oncologico Cooperativo Chileno de Investigation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, run by Grupo Oncologico Cooperativo Chileno de Investigation at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of downstaging (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01633203, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.