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

NCT06644352 | Recruiting DMC

• 1 other identifier: YLI
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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

Keywords

GastroEsophageal Cancer; Surgical Incision; Left thoracic incision; Right thoracic incision; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• OS rate

  OS is defined as the time from randomization to death due to any cause.

  5 years

Secondary Outcomes (4)

• DFS rate

  3 years

• pCR rate

  1 month after resection

• MPR rate

  1 month after resection

• Operative Complications

  perioperative period

Study Arms (2)

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).

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).

Procedure: different thoracic surgical approaches

Interventions

different thoracic surgical approaches PROCEDURE

Right Versus Left Thoracic Surgical Approaches

Left thoracic approach; Right thoracic approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Yin Li, MD

CONTACT

+8601087788052; liyin@cicams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: October 16, 2024
• Study Start: July 1, 2022
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

CN (1)