Comparison of Endoscopic Resection and Surgery for Early Gastric Cancer With Undifferentiated Histological Type (ERASE-GC)

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.

Study Overview

• Status: Recruiting
• Conditions: Stomach Cancer; Undifferentiated Type; Expanded Indication of Endoscopic Resection
• Intervention / Treatment: Procedure: Endoscopic submucosal dissection; Procedure: 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 Type: Interventional
• Enrollment (Estimated): 708
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Il Ju Choi, MD, PhD; Phone Number: +82-31-920-2282; Email: cij1224@ncc.re.kr
• Study Contact Backup: Name: Young-Il Kim, MD, PhD; Phone Number: +82-31-920-1712; Email: 11996@ncc.re.kr

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Goyang, Gyeonggi, Korea, Republic of, 410-769
      • Recruiting
      • National Cancer Center, Korea
      • Contact: Il Ju Choi, M.D., Ph.D.; Phone Number: +82-31-920-2282; Email: cij1224@hanmail.net
      • Principal Investigator: Il Ju Choi, M.D.,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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
2. Adult patients aged 19-75 years
3. Patients who had willingness to sign an informed consent form

Exclusion Criteria:

1. Patient age: < 19 years or age > 75 years
2. Diagnosis and active treatment for other organ cancer except carcinoma in situ and non-melanomatous skin cancer within 5 years
3. Previous gastrectomy or esophagectomy history
4. Multiple gastric cancers
5. 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
6. Inability to provide an informed consent
7. Inadequate conditions for study enrollment according to the evaluation of study physicians

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endoscopic treatment arm; Endoscopic submucosal dissection	Procedure: Endoscopic submucosal dissection; Endoscopic submucosal dissection by a endoscopist using endoscopic devices
Active Comparator: Surgical treatment group; Gastrectomy with lymph node dissection	Procedure: Surgery; Gastrectomy with lymph node dissection by a surgeon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease-free survival in the ITT population	Disease-free survival (gastric cancer recurrence or death from any causes)	3 years after the last participant enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease-free survival in the PP population	Disease-free survival (gastric cancer recurrence or death from any causes)	3 years after the last participant enrollment
Overall survival	Overall survival (death from any causes)	5 years after the last participant enrollment
Curative resection rate of ESD	Curative resection on the final pathological evaluation	2 year after the participant enrollment
Quality of life changes during follow-up periods	QoL changes using questionnaire	3 years after the last participant enrollment
Treatment related complications (adverse events)	Early (within 30 postoperative days) and late complications (after 30 postoperative days)	3 years after the last participant enrollment
Cost-effectiveness measured with Incremental cost effective ratio (ICER)		3 years after the last participant enrollment

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Collaborators: Seoul St. Mary's Hospital, The Catholic University; Chilgok Kyungpook National University Hospital; Pusan National University Hospital; Samsung Medical Center, Sungkyunkwan University School of Medicine; Severance Hospital, Yonsei University College of Medicine; Gangnam Severance Hospital, Yonsei University College of Medicine; Asan Medical Center; Chonnam National University Hospital
• Investigators: Principal Investigator: Il Ju Choi, MD, PhD, National Cancer Center, Korea

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 15, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Early gastric cancer; Endoscopic submucosal dissection; Surgery; Undifferentiated type; Expanded indication
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: NCC2021-0117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No