Stomach CancerERASE-GCNCT04890171
Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type
A study testing Endoscopic submucosal dissection and Surgery in people with Stomach Cancer and Undifferentiated Type, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This multi-center, randomized controlled trial is designed to evaluate clinical effectiveness and cost-effectiveness of ESD for undifferentiated type of EGC meeting the expanded indication compared with surgery. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Stomach Cancer, Undifferentiated Type, Expanded Indication of Endoscopic Resection
- What is being tested?
- Endoscopic submucosal dissection and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Jun 2021to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with undifferentiated type EGC (signet ring cell carcinoma, poorly differentiated tubular adenocarcinoma, or poorly cohesive carcinoma) that meets the expanded indication of ESD 1) Tumor confined to the mucosa without ulcer, and size ≤2 cm on endoscopic evaluations 2) No evidence of lymph node metastasis and distant metastasis on abdominal CT scan
- Adult patients aged 19-75 years
- Patients who had willingness to sign an informed consent form
Who cannot join
- Patient age: < 19 years or age > 75 years
- Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years
- Previous gastrectomy or esophagectomy history
- Multiple gastric cancers
- Current treatment for serious medical condition which could hinder study participation including severe heart dysfunction, liver cirrhosis, renal failure, chronic obstructive pulmonary disease or asthma, or uncontrolled infection
- Inability to provide an informed consent
- Inadequate conditions for study enrollment according to the evaluation of study physicians
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center, Korea
Goyang-si, Gyeonggi-do, 410-769
Il Ju Choi, M.D., Ph.D., +82-31-920-2282, cij1224@hanmail.net
Il Ju Choi, M.D.,Ph.D
About this study
Official title: Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type: a Multicenter Randomized Controlled Trial (ERASE-GC Trial)
This multi-center, randomized controlled trial is designed to evaluate clinical effectiveness and cost-effectiveness of ESD for undifferentiated type of EGC meeting the expanded indication compared with surgery.
Read the detailed description
Endoscopic submucosal dissection (ESD) is a minimally invasive treatment of early gastric cancer (EGC). Because of the stomach preservation, ESD provides a better quality of life (QoL) in EGC patients than surgery. In addition, medical costs are lower in patients underwent ESD than in those underwent surgery. In 2018, gastric cancer management guidelines by the Korean Gastric Cancer Association and Japanese Gastric Cancer Association (JGCA) stated that undifferentiated type of EGC, clinically diagnosed as tumor confined to the mucosa without ulcer, and size ≤2 cm, is included in the expanded indication of ESD. In the 2018 JGCA guideline (version 5), ESD is an investigational treatment for patients with undifferentiated type of EGC meeting the expanded indication whereas surgery (gastrectomy with lymph node dissection) is a standard treatment. Previous single center retrospective studies reported favorable long-term outcomes of ESD for undifferentiated type EGC meeting the expanded criteria on final pathological evaluations compared with that of surgery. More recently, a multi-center retrospective cohort study including 18 Korean university hospitals also reported no significant difference in overall mortality between ESD and surgery after propensity score matching (hazard ratio [HR] for overall mortality in the ESD group, 2.36; 95% confidence interval [CI] 0.91-6.10; p=0.078) during a median follow-up of 75.6 months. However, gastric cancer recurrence occurred only in the ESD group, and the HR for gastric cancer recurrence in the ESD group was 25.49 (95% CI 1.32-491.27; p=0.032). The 3-year disease-free survival (DFS) rate including gastric cancer recurrence or death was 94.9% in the ESD group and 98.1% in the surgery group. Thus, surgery group had a better DFS than ESD group (p=0.002 by log-rank test), and the HR for gastric cancer recurrence or death in the surgery group compared with the ESD group was 0.26 (95% CI, 0.10-0.64; p=0.003). However, previous studies could provide only a low level of evidence because of study limitations including the retrospective study design and incomplete data of patient survival and gastric cancer recurrence during follow-up. The studies did not evaluate QoL and cost-effectiveness after ESD and surgery. Therefore, we designed a multi-center, randomized controlled trial to provide a high level of evidence for clinical effectiveness and cost-effectiveness of ESD for undifferentiated type of EGC meeting the expanded indication.
- Being tested
- Endoscopic submucosal dissection, Surgery
- Keywords
- Early gastric cancer, Endoscopic submucosal dissection, Surgery, Undifferentiated type, Expanded indication
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic submucosal dissectionProcedure or surgery
Endoscopic submucosal dissection by a endoscopist using endoscopic devices
SurgeryProcedure or surgery
Gastrectomy with lymph node dissection by a surgeon
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic treatment arm | Active comparator | Endoscopic submucosal dissection Receives: Procedure: Endoscopic submucosal dissection |
| Surgical treatment group | Active comparator | Gastrectomy with lymph node dissection Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival in the ITT population
Disease-free survival (gastric cancer recurrence or death from any causes)
Measured: 3 years after the last participant enrollment
Secondary outcomes (6)
3-year disease-free survival in the PP population
Disease-free survival (gastric cancer recurrence or death from any causes)
Measured: 3 years after the last participant enrollment
Overall survival
Overall survival (death from any causes)
Measured: 5 years after the last participant enrollment
Curative resection rate of ESD
Curative resection on the final pathological evaluation
Measured: 2 year after the participant enrollment
Quality of life changes during follow-up periods
QoL changes using questionnaire
Measured: 3 years after the last participant enrollment
Treatment related complications (adverse events)
Early (within 30 postoperative days) and late complications (after 30 postoperative days)
Measured: 3 years after the last participant enrollment
Cost-effectiveness measured with Incremental cost effective ratio (ICER)
Measured: 3 years after the last participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start11 Jun 2021
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 708 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Collaborators
- Seoul St. Mary's Hospital, Kyungpook National University Chilgok Hospital, Pusan National University Hospital, Samsung Medical Center, Severance Hospital, Gangnam Severance Hospital, Yonsei University College of Medicine, Asan Medical Center, Chonnam National University Hospital
- Responsible party
- Principal investigator, Il Ju Choi, National Cancer Center, Korea
- Investigators
- Il Ju Choi, MD, PhD, Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890171
- Sponsor's protocol ID
- NCC2021-0117
- Acronym
- ERASE-GC
- Status last verified
- Dec 2024
- First submitted
- 11 May 2021
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type: a Multicenter Randomized Controlled Trial (ERASE-GC Trial)
- ClinicalTrials.gov ID
- NCT04890171
- Acronym / sponsor ID
- ERASE-GC / NCC2021-0117
- Keywords
- Early gastric cancer, Endoscopic submucosal dissection, Surgery, Undifferentiated type, Expanded indication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 708 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Collaborators
- Seoul St. Mary's Hospital, Kyungpook National University Chilgok Hospital, Pusan National University Hospital, Samsung Medical Center, Severance Hospital, Gangnam Severance Hospital, Yonsei University College of Medicine, Asan Medical Center, Chonnam National University Hospital
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 18 May 2021 (actual)
- 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 multi-center, randomized controlled trial is designed to evaluate clinical effectiveness and cost-effectiveness of ESD for undifferentiated type of EGC meeting the expanded indication compared with surgery.
Detailed description
Endoscopic submucosal dissection (ESD) is a minimally invasive treatment of early gastric cancer (EGC). Because of the stomach preservation, ESD provides a better quality of life (QoL) in EGC patients than surgery. In addition, medical costs are lower in patients underwent ESD than in those underwent surgery. In 2018, gastric cancer management guidelines by the Korean Gastric Cancer Association and Japanese Gastric Cancer Association (JGCA) stated that undifferentiated type of EGC, clinically diagnosed as tumor confined to the mucosa without ulcer, and size ≤2 cm, is included in the expanded indication of ESD. In the 2018 JGCA guideline (version 5), ESD is an investigational treatment for patients with undifferentiated type of EGC meeting the expanded indication whereas surgery (gastrectomy with lymph node dissection) is a standard treatment. Previous single center retrospective studies reported favorable long-term outcomes of ESD for undifferentiated type EGC meeting the expanded criteria on final pathological evaluations compared with that of surgery. More recently, a multi-center retrospective cohort study including 18 Korean university hospitals also reported no significant difference in overall mortality between ESD and surgery after propensity score matching (hazard ratio [HR] for overall mortality in the ESD group, 2.36; 95% confidence interval [CI] 0.91-6.10; p=0.078) during a median follow-up of 75.6 months. However, gastric cancer recurrence occurred only in the ESD group, and the HR for gastric cancer recurrence in the ESD group was 25.49 (95% CI 1.32-491.27; p=0.032). The 3-year disease-free survival (DFS) rate including gastric cancer recurrence or death was 94.9% in the ESD group and 98.1% in the surgery group. Thus, surgery group had a better DFS than ESD group (p=0.002 by log-rank test), and the HR for gastric cancer recurrence or death in the surgery group compared with the ESD group was 0.26 (95% CI, 0.10-0.64; p=0.003). However, previous studies could provide only a low level of evidence because of study limitations including the retrospective study design and incomplete data of patient survival and gastric cancer recurrence during follow-up. The studies did not evaluate QoL and cost-effectiveness after ESD and surgery. Therefore, we designed a multi-center, randomized controlled trial to provide a high level of evidence for clinical effectiveness and cost-effectiveness of ESD for undifferentiated type of EGC meeting the expanded indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic treatment arm | Active comparator | Procedure: Endoscopic submucosal dissectionEndoscopic submucosal dissection |
| Surgical treatment group | Active comparator | Procedure: SurgeryGastrectomy with lymph node dissection |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are diagnosed with undifferentiated type EGC (signet ring cell carcinoma, poorly differentiated tubular adenocarcinoma, or poorly cohesive carcinoma) that meets the expanded indication of ESD 1) Tumor confined to the mucosa without ulcer, and size ≤2 cm on endoscopic evaluations 2) No evidence of lymph node metastasis and distant metastasis on abdominal CT scan
- Adult patients aged 19-75 years
- Patients who had willingness to sign an informed consent form
Key exclusion criteria (7 listed)
- Patient age: < 19 years or age > 75 years
- Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years
- Previous gastrectomy or esophagectomy history
- Multiple gastric cancers
- Current treatment for serious medical condition which could hinder study participation including severe heart dysfunction, liver cirrhosis, renal failure, chronic obstructive pulmonary disease or asthma, or uncontrolled infection
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 |
|---|---|---|
| Endoscopic submucosal dissectionEndoscopic submucosal dissection by a endoscopist using endoscopic devices | Procedure or surgery | Endoscopic treatment arm |
| SurgeryGastrectomy with lymph node dissection by a surgeon | Procedure or surgery | Surgical treatment group |
Primary outcome
3-year disease-free survival in the ITT population
Time frame: 3 years after the last participant enrollment
Disease-free survival (gastric cancer recurrence or death from any causes)
6 secondary outcomes
3-year disease-free survival in the PP population
Time frame: 3 years after the last participant enrollment
Overall survival
Time frame: 5 years after the last participant enrollment
Curative resection rate of ESD
Time frame: 2 year after the participant enrollment
Quality of life changes during follow-up periods
Time frame: 3 years after the last participant enrollment
Treatment related complications (adverse events)
Time frame: 3 years after the last participant enrollment
Cost-effectiveness measured with Incremental cost effective ratio (ICER)
Time frame: 3 years after the last participant enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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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.
Il Ju Choi, MD, PhD principal investigator
National Cancer Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic submucosal dissection and Surgery in people with Stomach Cancer and Undifferentiated Type, run by National Cancer Center, Korea 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Il Ju Choi, MD, PhD (+82-31-920-2282, cij1224@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease-free survival in the ITT population (time frame: 3 years after the last participant enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.