Siewert Type II Adenocarcinoma of Esophagogastric JunctionNCT06644352
Right Versus Left Thoracic Surgical Approaches for Siewert II Gastroesophageal Junction Adenocarcinoma
A study testing different thoracic surgical approaches in people with Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To explore the 5-year overall survival (OS) of right versus left thoracic surgical approaches for patients with locally advanced Siewert II gastroesophageal junction adenocarcinoma treated by neoadjuvant chemotherapy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Siewert Type II Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- different thoracic surgical approaches
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jul 2027
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed gastroesophageal adenocarcinoma;
- R0 resectable Siewert Ⅱ, cT2-3N0-3M0 (AJCC V8 TNM classification);
- Have a performance status of 0 or 1 on the ECOG Performance Scale;
- Age 18-80 years old, both men and women;
- Estimated survival ≥6 months;
- Be willing and able to provide written informed consent/assent for the trial;
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- Demonstrate adequate organ function ;
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 7 days before enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
- Have not received systemic or local treatment for esophageal cancer in the past.
Who cannot join
- Have a history of other malignant tumors in the past or at the same time;
- Previous upper abdominal surgery (excluding cholecystectomy);
- Bleeding, perforation and obstruction requiring emergency surgical treatment;
- Severe heart, lung, liver and kidney dysfunction, which the researcher thinks is not suitable for operation;
- Hydrothorax and ascites with clinical symptoms need therapeutic puncture or drainage;
- Participate in other clinical studies or less than 1 month from the end of the previous clinical study;
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- Have a history of psychoactive drug abuse, alcoholism or drug abuse;
- Be unable or do not agree to bear the inspection and treatment expenses at their own expense;
- The researcher thinks that it should be excluded from this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Yin Li, MD, 861087788052, liyin@cicams.ac.cn
About this study
Official title: A Prospective, Randomized, Controlled, Multicenter Study Comparing the Right Versus Left Thoracic Surgical Approaches for Locally Advanced Siewert II Gastroesophageal Junction Adenocarcinoma After Neoadjuvant Chemotherapy
To explore the 5-year overall survival (OS) of right versus left thoracic surgical approaches for patients with locally advanced Siewert II gastroesophageal junction adenocarcinoma treated by neoadjuvant chemotherapy
- Being tested
- different thoracic surgical approaches
- Keywords
- GastroEsophageal Cancer, Surgical Incision, Left thoracic incision, Right thoracic incision, Neoadjuvant chemotherapy
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different thoracic surgical approachesProcedure or surgery
Right Versus Left Thoracic Surgical Approaches
| Study group | Role | What they receive |
|---|---|---|
| Right thoracic approach | Experimental | Neoadjuvant therapy+surgery+adjuvant therapy. Neoadjuvant therapy: chemotherapy with 2-4 cycles； Surgery: dissociate the stomach and operate the gastroesophagostomy and lower mediastinal lymphadenectomy by the right thoracic approach (right thoracic incision); Adjuvant therapy: perioperative chemotherapy with total 8 cycles (including neoadjuvant chemotherapy). Receives: Procedure: different thoracic surgical approaches |
| Left thoracic approach | Active comparator | Neoadjuvant therapy+surgery+adjuvant therapy. Neoadjuvant therapy: chemotherapy with 2-4 cycles； Surgery: dissociate the stomach and operate the gastroesophagostomy and lower mediastinal lymphadenectomy by the left thoracic approach (including right thoracic and abdominal incision); Adjuvant therapy: perioperative chemotherapy with total 8 cycles (including neoadjuvant chemotherapy). Receives: Procedure: different thoracic surgical approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS rate
OS is defined as the time from randomization to death due to any cause.
Measured: 5 years
Secondary outcomes (4)
DFS rate
DFS is defined as the time from randomization to the first documented disease progression of local recurrence or distant metastasis or death due to any cause.
Measured: 3 years
pCR rate
PCR is defined as pT0N0M0
Measured: 1 month after resection
MPR rate
MPR is defined as viable tumor comprised ≤ 10% of resected tumor specimens.
Measured: 1 month after resection
Operative Complications
Operative Complications
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jul 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Siewert Type II Adenocarcinoma of Esophagogastric JunctionStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 236 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644352
- Sponsor's protocol ID
- YLI
- Status last verified
- Oct 2024
- First submitted
- 12 Jul 2024
- Last updated
- 16 Oct 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multicenter Study Comparing the Right Versus Left Thoracic Surgical Approaches for Locally Advanced Siewert II Gastroesophageal Junction Adenocarcinoma After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT06644352
- Acronym / sponsor ID
- YLI
- Keywords
- GastroEsophageal Cancer, Surgical Incision, Left thoracic incision, Right thoracic incision, Neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Oct 2024 (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.
To explore the 5-year overall survival (OS) of right versus left thoracic surgical approaches for patients with locally advanced Siewert II gastroesophageal junction adenocarcinoma treated by neoadjuvant chemotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right thoracic approach | Experimental | Procedure: different thoracic surgical approachesNeoadjuvant therapy+surgery+adjuvant therapy. Neoadjuvant therapy: chemotherapy with 2-4 cycles； Surgery: dissociate the stomach and operate the gastroesophagostomy and lower mediastinal lymphadenectomy by the right thoracic approach (right thoracic incision); Adjuvant therapy: perioperative chemotherapy with total 8 cycles (including neoadjuvant chemotherapy). |
| Left thoracic approach | Active comparator | Procedure: different thoracic surgical approachesNeoadjuvant therapy+surgery+adjuvant therapy. Neoadjuvant therapy: chemotherapy with 2-4 cycles； Surgery: dissociate the stomach and operate the gastroesophagostomy and lower mediastinal lymphadenectomy by the left thoracic approach (including right thoracic and abdominal incision); Adjuvant therapy: perioperative chemotherapy with total 8 cycles (including neoadjuvant chemotherapy). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed gastroesophageal adenocarcinoma;
- R0 resectable Siewert Ⅱ, cT2-3N0-3M0 (AJCC V8 TNM classification);
- Have a performance status of 0 or 1 on the ECOG Performance Scale;
- Age 18-80 years old, both men and women;
- Estimated survival ≥6 months;
Key exclusion criteria (9 listed)
- Have a history of other malignant tumors in the past or at the same time;
- Previous upper abdominal surgery (excluding cholecystectomy);
- Bleeding, perforation and obstruction requiring emergency surgical treatment;
- Severe heart, lung, liver and kidney dysfunction, which the researcher thinks is not suitable for operation;
- Hydrothorax and ascites with clinical symptoms need therapeutic puncture or drainage;
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 |
|---|---|---|
| different thoracic surgical approachesRight Versus Left Thoracic Surgical Approaches | Procedure or surgery | Left thoracic approach, Right thoracic approach |
Primary outcome
OS rate
Time frame: 5 years
OS is defined as the time from randomization to death due to any cause.
4 secondary outcomes
DFS rate
Time frame: 3 years
pCR rate
Time frame: 1 month after resection
MPR rate
Time frame: 1 month after resection
Operative Complications
Time frame: perioperative period
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 16 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing different thoracic surgical approaches in people with Siewert Type II Adenocarcinoma of Esophagogastric Junction, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 9 inclusion and 9 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 16 Oct 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 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?
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 Yin Li, MD (+8601087788052, liyin@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS rate (time frame: 5 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 16 Oct 2024.