Advanced Gastric Cancer With Serosal InvasionPhase 3EPIC-GCNCT02205008
Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
A Phase 3 study testing surgery, adjuvant systemic chemotherapy and Early postoperative intraperitoneal chemothgerapy in people with Advanced Gastric Cancer With Serosal Invasion, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal chemotherapy have been published. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Advanced Gastric Cancer With Serosal Invasion
- What is being tested?
- surgery, adjuvant systemic chemotherapy and Early postoperative intraperitoneal chemothgerapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2012to Nov 2018
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven adenocarcinoma of the stomach
- preoperative suspicion of serosal invasion on the radiological examination
- candidate for curative resection of the stomach with D2
- age from 19 to 70 year old
- Eastern Cooperative Oncology Group Performance status :0, 1, or 2
- absolute neutrophil count≥1,500/microliter, hemoglobin≥9.0g/dL, and platelet≥100,000/microliter
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- serum Creatinine<1.5mg/dL
- total bilirubin <2 x upper normal limit, transaminase<3 x upper normal limit
- patients without previous administration of chemotherapeutic agent
- patients who agreed and signed to the informed consent form
Who cannot join
- malignancy of the stomach except for adenocarcinoma
- history of hypersensitivity to 5-fluorouracil or mitomycin
- concomitant infectious disease
- active hepatitis or chronic liver disease
- history of psychotic disorders
- patients with disorders in the central nervous system
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- history of other malignancy within 5 years
- history of clinically significant heart disease (congestive heart failure, symptomatic coronary artery disease, symptomatic arrhythmia, myocardial infarction)
- patients with increased bleeding tendency
- pregnant or lactating female patients
- patient who did not agreed and signed to the informed consent form
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kyungpook National University Medical Center Gastric Cancer Center
Daegu, 702-210
Wansik Yu, MD, PhD, 82-53-200-2700, wyu@nknu.ac.kr
Wansik Yu, MD, PhD
About this study
Official title: Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal chemotherapy have been published.
In this study, we review the clinicopathological characteristics of patients and effects of early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric cancer-specific survival and patterns of recurrence of gastric cancer patients with macroscopic serosal invasion.
The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall and disease free survival of advanced gastric cancer patients with serosal invasion after potentially curative surgery.
- Being tested
- surgery, adjuvant systemic chemotherapy, Early postoperative intraperitoneal chemothgerapy
- Keywords
- advanced gastric cancer, serosal invasion, peritoneal recurrence, intraperitoneal chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
Total or subtotal gastrectomy with D2
adjuvant systemic chemotherapyDrug
adjuvant systemic chemotherapy with S-1 (<1.25m2:40mg, 1.25-1.5m2:50mg, >1.5m2:60mg, bid)
Early postoperative intraperitoneal chemothgerapyDrug
operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2
1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | curative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1 Receives: Procedure: surgery; Drug: adjuvant systemic chemotherapy; Drug: Early postoperative intraperitoneal chemothgerapy |
| Arm B | Placebo comparator | curative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1 Receives: Procedure: surgery; Drug: adjuvant systemic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
relapsed free survival
during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded
Measured: postoperative 3 years
Secondary outcomes (1)
overall survival
during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded
Measured: postoperative 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startOct 2012
- Primary completionDec 2015 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Gastric Cancer With Serosal InvasionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Center, Korea, Keimyung University Dongsan Medical Center, Yeungnam University Hospital, Daegu Catholic University Medical Center, Chonnam National University Hospital, Dong-A University Hospital, Severance Hospital, Korea Cancer Center Hospital, Chung-Ang University Hospital, Hanyang University
- Responsible party
- Principal investigator, Wansik Yu, Kyungpook National University Hospital
- Investigators
- Wansik Yu, MD. PhD, Principal investigator, Kyungpook National University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205008
- Sponsor's protocol ID
- EPIC-GC
- Other IDs
- KNUMCGCC-001
- Acronym
- EPIC-GC
- Status last verified
- Jul 2014
- First submitted
- 26 Jul 2014
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
1. Maruyama K, Okabayashi K, Kinoshita T. Progress in gastric cancer surgery in Japan and its limits of radicality. World J Surg 1987;11:418-425. 2. Lee JL, Kang HJ, Kang YK, et al. Phase I/II study of 3-week combination of S-1 and cisplatin chemotherapy for metastatic or recurent gastric cancer. Cancer Chemother Pharmacol 2007 (E-pub). 3. Schoffski P. The modulated oral fluoropyrimidine prodrug S-1, and its use in gastrointestinal cancer and other solid tumors. Anticancer Drug 2004;15:85-106. 4. Sugimachi K, Maehara Y, Horikoshi N et al. An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology 1999;57:202-210. 5. Koizumi W, Kurihara M, Nakajo S et al. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology 2000;58:191-197. 6. Sakata Y, Ohtsu A, Horikoshi N et al. Late phase II study of novel oral fluoropyrimidine anticancer drugs S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 1998;34:1715-1720. 7. Nagashima F, Ohtsu A, Yoshida S et al. Japanese nationwide postmarketing survey of S-1 in patients with advanced gastric cancer. Gastric Cancer 2005;8:6-11. 8. Chollet P, Schoffski P, Weigang-Kohler K et al. Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC early clinical studies group (ECGC). Eur J Cancer 2003;39:1264-1270. 9. Ilson D. Just when you thought the fluorouracil debate was over: S-1 and gastric cancer. J Clin Oncol 2005;23:6826-6828. 10. Hoff PM, Saad ED, Ajani JA et al. Phase I study with pharmacokinetics of S-1, an oral daily schedule for 28 days in patients with solid tumors. Clin Cancer Res 2003;9:134-142. 11. Simon R. Optimal two-stage design for phase II clinical trials. Controlled Clin Trials 1989;10:1-10.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Multicenter Phase III Trial of Intraperitoneal Chemotherapy and Systemic Chemotherapy Versus Systemic Chemotherapy After Curative Resection of Serosa-positive Gastric Cancer
- ClinicalTrials.gov ID
- NCT02205008
- Acronym / sponsor ID
- EPIC-GC / EPIC-GC
- Keywords
- advanced gastric cancer, serosal invasion, peritoneal recurrence, intraperitoneal chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- National Cancer Center, Korea, Keimyung University Dongsan Medical Center, Yeungnam University Hospital, Daegu Catholic University Medical Center, Chonnam National University Hospital, Dong-A University Hospital, Severance Hospital, Korea Cancer Center Hospital, Chung-Ang University Hospital, Hanyang University
- Study start
- Oct 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 31 Jul 2014 (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.
Intraperitoneal chemotherapy as an adjuvant treatment modality is designed to eradicate intraperitoneal free tumor cells that can be a source of peritoneal carcinomatosis. Although we have not reached unanimous consensus, favorable reports on the outcome of intraperitoneal chemotherapy have been published.
In this study, we review the clinicopathological characteristics of patients and effects of early postoperative intraperitoneal chemotherapy (EPIC) on overall and gastric cancer-specific survival and patterns of recurrence of gastric cancer patients with macroscopic serosal invasion.
The aim of this study is to evaluate the impact of intraperitoneal chemotherapy on overall and disease free survival of advanced gastric cancer patients with serosal invasion after potentially curative surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Procedure: surgery, Drug: adjuvant systemic chemotherapy, Drug: Early postoperative intraperitoneal chemothgerapycurative resection of the stomach with D2 plus intraperitoneal chemotherapy plus adjuvant systemic chemotherapy with S-1 |
| Arm B | Placebo comparator | Procedure: surgery, Drug: adjuvant systemic chemotherapycurative resection of the stomach with D2 plus adjuvant systemic chemotherapy with S-1 |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- histologically proven adenocarcinoma of the stomach
- preoperative suspicion of serosal invasion on the radiological examination
- candidate for curative resection of the stomach with D2
- age from 19 to 70 year old
- Eastern Cooperative Oncology Group Performance status :0, 1, or 2
Key exclusion criteria (11 listed)
- malignancy of the stomach except for adenocarcinoma
- history of hypersensitivity to 5-fluorouracil or mitomycin
- concomitant infectious disease
- active hepatitis or chronic liver disease
- history of psychotic disorders
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 |
|---|---|---|
| surgeryTotal or subtotal gastrectomy with D2 | Procedure or surgery | Arm A, Arm B |
| adjuvant systemic chemotherapyadjuvant systemic chemotherapy with S-1 (<1.25m2:40mg, 1.25-1.5m2:50mg, >1.5m2:60mg, bid) | Drug | Arm A, Arm B |
| Early postoperative intraperitoneal chemothgerapyoperation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2 1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq | Drug | Arm A |
Primary outcome
relapsed free survival
Time frame: postoperative 3 years
during regular follow-up with blood test, radiologic, endoscopic surveillance patients with recurrence will be detected and recorded
1 secondary outcome
overall survival
Time frame: postoperative 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Background1. Maruyama K, Okabayashi K, Kinoshita T. Progress in gastric cancer surgery in Japan and its limits of radicality. World J Surg 1987;11:418-425. 2. Lee JL, Kang HJ, Kang YK, et al. Phase I/II study of 3-week combination of S-1 and cisplatin chemotherapy for metastatic or recurent gastric cancer. Cancer Chemother Pharmacol 2007 (E-pub). 3. Schoffski P. The modulated oral fluoropyrimidine prodrug S-1, and its use in gastrointestinal cancer and other solid tumors. Anticancer Drug 2004;15:85-106. 4. Sugimachi K, Maehara Y, Horikoshi N et al. An early phase II study of oral S-1, a newly developed 5-fluorouracil derivative for advanced and recurrent gastrointestinal cancers. Oncology 1999;57:202-210. 5. Koizumi W, Kurihara M, Nakajo S et al. Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. Oncology 2000;58:191-197. 6. Sakata Y, Ohtsu A, Horikoshi N et al. Late phase II study of novel oral fluoropyrimidine anticancer drugs S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 1998;34:1715-1720. 7. Nagashima F, Ohtsu A, Yoshida S et al. Japanese nationwide postmarketing survey of S-1 in patients with advanced gastric cancer. Gastric Cancer 2005;8:6-11. 8. Chollet P, Schoffski P, Weigang-Kohler K et al. Phase II trial with S-1 in chemotherapy-naïve patients with gastric cancer. A trial performed by the EORTC early clinical studies group (ECGC). Eur J Cancer 2003;39:1264-1270. 9. Ilson D. Just when you thought the fluorouracil debate was over: S-1 and gastric cancer. J Clin Oncol 2005;23:6826-6828. 10. Hoff PM, Saad ED, Ajani JA et al. Phase I study with pharmacokinetics of S-1, an oral daily schedule for 28 days in patients with solid tumors. Clin Cancer Res 2003;9:134-142. 11. Simon R. Optimal two-stage design for phase II clinical trials. Controlled Clin Trials 1989;10:1-10.
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.
Wansik Yu, MD. PhD principal investigator
Kyungpook National University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing surgery, adjuvant systemic chemotherapy and Early postoperative intraperitoneal chemothgerapy in people with Advanced Gastric Cancer With Serosal Invasion, run by Kyungpook National University Hospital at 1 site in South Korea.
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 10 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: status not confirmed, as of the sponsor's last update on 31 Jul 2014. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wansik Yu, MD, PhD, FACS (82-53-200-2700, wyu@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relapsed free survival (time frame: postoperative 3 years). 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 NCT02205008, which also lists 1 linked publication.
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 31 Jul 2014.