Stomach NeoplasmsNCT02313688
Length of the Proximal Resection Margin for Siewert-II/Siewert-III Tumors
A study testing gastrectomy in people with Stomach Neoplasms and Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by West China Hospital at 1 site in China.
Trial summary
The incidence of adenocarcinomas of the esophagogastric junction (AEJ) has increased rapidly during the past decades. By the Siewert classification, the AEJ is the tumor center located 5 cm above the anatomic cardia and 5 cm below it, which is divided into three individual subtypes. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stomach Neoplasms, Siewert Type II Adenocarcinoma of Esophagogastric Junction, Recurrence
- What is being tested?
- gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2023
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative endoscopy and biopsy confirmed upper third gastric adenocarcinoma (Siewert-II/Siewert-III), and predictively feasible of radical total gastrectomy;
- Predictively resectable diseases, advanced gastric cancer, of preoperative staging JGCA 14th Edition cT2N0M0-T4aN3bM0, Ib-IIIc stage;
- Age：≤75 years, or ≥18 years;
- Without serious disease and malignance disease;
- WHO performance score ≤2, ASA score ≤3;
- No limit to sexual and race;
- Informed consent required.
Who cannot join
- Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc;
- Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
- Severity mental diseases;
- Primary lesion cannot be resected in the pattern of transabdominal proximal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
- After signature the Clinical trial agreement, patients and their agent will quit the trial.
Trial locations and contacts
1 site in 1 country.
Wei-Han Zhang, M.D. contact
Xin-Zu Chen, M.D. contact
China1 site, 1 recruiting
- Recruiting
West China Hospital
Chengdu, Sichuan, 610041
Wei-Han Zhang, M.D., weihanwch@126.com
Xin-Zu Chen, M.D., chen_xz_wch_scu@126.com
About this study
Official title: The Relationship Between the Length of the Proximal Resection Margin and Long-term Survival for Adenocarcinomas of the Esophagogastric Junction (Siewert-II/Siewert-III)- Randomized Controlled Trial
The incidence of adenocarcinomas of the esophagogastric junction (AEJ) has increased rapidly during the past decades. By the Siewert classification, the AEJ is the tumor center located 5 cm above the anatomic cardia and 5 cm below it, which is divided into three individual subtypes. Complete tumor resection is the primary therapy strategies for tumors of the AEJ. The Japan Clinical Oncology Group 9502 (JCOG 9502) found that transabdominal or transhiatal approach gastrectomy has better survival outcomes compared with left thoracoabdominal approach surgery for Siewert II/III tumors. Transabdominal approach gastrectomy is recommended as the standard treatment strategy for Siewert II/III tumors by the guidelines of the Japanese Gastric Cancer Association (JGCA). However, the length of the proximal resection margin for Siewert-II/III tumors by transabdominal/transhiatal gastrectomy is still controversies. Previous study found that longer than 2cm proximal resection margin had better survival outcome than less than 2cm proximal resection margin for Siewert-II/III tumors. On the other sides, due to more advanced tumor stage of patients in China when compared with Japan and Korea. It is necessary to conduct a randomized control study to analyze the length of resection margin in advanced adenocarcinomas of esophagogastric junction.
Therefore, this study was aimed to include those Siewert II/III tumor patients in Gastrointestinal Surgery Department, West China Hospital, Sichuan University to analyze the relationship between the length of proximal resection margin and survival outcomes.
Read the detailed description
Standard Operating Procedure (SOP)
- Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
- Randomization: Intraoperative evaluation found that transabdominal or transhiatal R0, D2 lymphadenectomy, total gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
- Surgical procedures: The surgical treatments is adopted the total gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Patients in the Group A with 3cm length proximal resection margin and patients in the Group B with 5cm length proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin. If the positive resection margin is found by the intraoperative frozen section, supplementary resection was depend on the characteristics of each patients. Whether these patients with supplementary resection, the length of supplementary resection and the times of the supplementary resection are all needed to record. The two study will take the similar surgical procedures except for the length of the resection margin.
- Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
- Follow-up: The follow-up of this study divide into two parts, the postoperative complications and survival outcomes. The postoperative complications is graded by the Clavien-Dindo classification. The survival outcomes included recurrence type, relapse free survival (months) and the overall survival (months).
- Conditions
- Stomach Neoplasms, Siewert Type II Adenocarcinoma of Esophagogastric Junction, Recurrence, Siewert Type III Adenocarcinoma of Esophagogastric Junction
- Being tested
- gastrectomy
- Keywords
- adenocarcinomas of esophagogastric junction, resection margin, length, prognosis
- Medical subject headings
- Stomach Neoplasms, Recurrence, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrectomyProcedure or surgery
Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 3±0.5 cm lengthen proximal resection margin.
gastrectomyProcedure or surgery
Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 5±0.5 cm lengthen proximal resection margin.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: Patients in the Group A will underwent D2 total gastrectomy and with 3±0.5 cm lengthen proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin. Receives: Procedure: gastrectomy |
| Group B | Experimental | Patients in the Group B will underwent D2 total gastrectomy and with 5±0.5 cm lengthen proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin. Receives: Procedure: gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival
Measured: 3 years
Secondary outcomes (3)
3-year overall survival
Measured: 3 years
Recurrence type
Measured: 3 years
The positive rate of proximal resection margin
Examined by the intraoperative frozen section
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Kun Hu, West China Hospital
- Investigators
- Jian-Kun Hu, M.D. Ph.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02313688
- Sponsor's protocol ID
- WCH-GC-02
- Status last verified
- Dec 2017
- First submitted
- 7 Dec 2014
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Length of the Proximal Resection Margin and Long-term Survival for Adenocarcinomas of the Esophagogastric Junction (Siewert-II/Siewert-III)- Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02313688
- Acronym / sponsor ID
- WCH-GC-02
- Conditions
- Stomach Neoplasms, Siewert Type II Adenocarcinoma of Esophagogastric Junction, Recurrence, Siewert Type III Adenocarcinoma of Esophagogastric Junction
- Keywords
- adenocarcinomas of esophagogastric junction, resection margin, length, prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Dec 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.
The incidence of adenocarcinomas of the esophagogastric junction (AEJ) has increased rapidly during the past decades. By the Siewert classification, the AEJ is the tumor center located 5 cm above the anatomic cardia and 5 cm below it, which is divided into three individual subtypes. Complete tumor resection is the primary therapy strategies for tumors of the AEJ. The Japan Clinical Oncology Group 9502 (JCOG 9502) found that transabdominal or transhiatal approach gastrectomy has better survival outcomes compared with left thoracoabdominal approach surgery for Siewert II/III tumors. Transabdominal approach gastrectomy is recommended as the standard treatment strategy for Siewert II/III tumors by the guidelines of the Japanese Gastric Cancer Association (JGCA). However, the length of the proximal resection margin for Siewert-II/III tumors by transabdominal/transhiatal gastrectomy is still controversies. Previous study found that longer than 2cm proximal resection margin had better survival outcome than less than 2cm proximal resection margin for Siewert-II/III tumors. On the other sides, due to more advanced tumor stage of patients in China when compared with Japan and Korea. It is necessary to conduct a randomized control study to analyze the length of resection margin in advanced adenocarcinomas of esophagogastric junction.
Therefore, this study was aimed to include those Siewert II/III tumor patients in Gastrointestinal Surgery Department, West China Hospital, Sichuan University to analyze the relationship between the length of proximal resection margin and survival outcomes.
Detailed description
Standard Operating Procedure (SOP)
- Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
- Randomization: Intraoperative evaluation found that transabdominal or transhiatal R0, D2 lymphadenectomy, total gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
- Surgical procedures: The surgical treatments is adopted the total gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Patients in the Group A with 3cm length proximal resection margin and patients in the Group B with 5cm length proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin. If the positive resection margin is found by the intraoperative frozen section, supplementary resection was depend on the characteristics of each patients. Whether these patients with supplementary resection, the length of supplementary resection and the times of the supplementary resection are all needed to record. The two study will take the similar surgical procedures except for the length of the resection margin.
- Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
- Follow-up: The follow-up of this study divide into two parts, the postoperative complications and survival outcomes. The postoperative complications is graded by the Clavien-Dindo classification. The survival outcomes included recurrence type, relapse free survival (months) and the overall survival (months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: gastrectomyGroup A: Patients in the Group A will underwent D2 total gastrectomy and with 3±0.5 cm lengthen proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin. |
| Group B | Experimental | Procedure: gastrectomyPatients in the Group B will underwent D2 total gastrectomy and with 5±0.5 cm lengthen proximal resection margin. Intraoperative frozen section will routinely performed to secure the tumor free resection margin. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Preoperative endoscopy and biopsy confirmed upper third gastric adenocarcinoma (Siewert-II/Siewert-III), and predictively feasible of radical total gastrectomy;
- Predictively resectable diseases, advanced gastric cancer, of preoperative staging JGCA 14th Edition cT2N0M0-T4aN3bM0, Ib-IIIc stage;
- Age：≤75 years, or ≥18 years;
- Without serious disease and malignance disease;
- WHO performance score ≤2, ASA score ≤3;
Key exclusion criteria (5 listed)
- Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc;
- Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
- Severity mental diseases;
- Primary lesion cannot be resected in the pattern of transabdominal proximal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection or with a transthoracic approach surgery;
- After signature the Clinical trial agreement, patients and their agent will quit the trial.
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 |
|---|---|---|
| gastrectomyTransabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 3±0.5 cm lengthen proximal resection margin. | Procedure or surgery | Group A |
| gastrectomyTransabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 5±0.5 cm lengthen proximal resection margin. | Procedure or surgery | Group B |
Primary outcome
3-year disease free survival
Time frame: 3 years
3 secondary outcomes
3-year overall survival
Time frame: 3 years
Recurrence type
Time frame: 3 years
The positive rate of proximal resection margin
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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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.
Wei-Han Zhang, M.D. contact
Xin-Zu Chen, M.D. contact
Jian-Kun Hu, M.D. Ph.D. principal investigator
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastrectomy in people with Stomach Neoplasms and Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by West China Hospital at 1 site in China.
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 7 inclusion and 5 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 11 Dec 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Han Zhang, M.D. (weihanwch@126.com), 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 (time frame: 3 years). 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 11 Dec 2017.