Right Versus Left Thoracic Surgical Approaches for Siewert II Gastroesophageal Junction Adenocarcinoma

NCT ID: NCT06644352

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2027-07-01

Brief 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

Conditions

Siewert Type II Adenocarcinoma of Esophagogastric Junction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Right thoracic approach

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).

Group Type: EXPERIMENTAL

different thoracic surgical approaches

Intervention Type: PROCEDURE

Right Versus Left Thoracic Surgical Approaches

Left thoracic approach

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).

Group Type: ACTIVE_COMPARATOR

different thoracic surgical approaches

Intervention Type: PROCEDURE

Right Versus Left Thoracic Surgical Approaches

Interventions

different thoracic surgical approaches

Right Versus Left Thoracic Surgical Approaches

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed gastroesophageal adenocarcinoma;

2. R0 resectable Siewert Ⅱ, cT2-3N0-3M0 (AJCC V8 TNM classification);

3. Have a performance status of 0 or 1 on the ECOG Performance Scale;

4. Age 18-80 years old, both men and women;

5. Estimated survival ≥6 months;

6. Be willing and able to provide written informed consent/assent for the trial;

7. Demonstrate adequate organ function ;

8. 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;

9. Have not received systemic or local treatment for esophageal cancer in the past.

Exclusion Criteria

1. Have a history of other malignant tumors in the past or at the same time;

2. Previous upper abdominal surgery (excluding cholecystectomy);

3. Bleeding, perforation and obstruction requiring emergency surgical treatment;

4. Severe heart, lung, liver and kidney dysfunction, which the researcher thinks is not suitable for operation;

5. Hydrothorax and ascites with clinical symptoms need therapeutic puncture or drainage;

6. Participate in other clinical studies or less than 1 month from the end of the previous clinical study;

7. Have a history of psychoactive drug abuse, alcoholism or drug abuse;

8. Be unable or do not agree to bear the inspection and treatment expenses at their own expense;

9. The researcher thinks that it should be excluded from this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yin Li, MD

Role: CONTACT

liyin@cicams.ac.cn

+8601087788052

Facility Contacts

Yin Li, MD

Role: primary

liyin@cicams.ac.cn

861087788052

Other Identifiers

YLI

Identifier Type: -

Identifier Source: org_study_id