Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma

Time Clinical Trial

Official title:

Exploring the Optimal Timing of Minimally Invasive Surgery for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06364566
• Other study ID #: time-exploring
• Status: Completed
• Phase: N/A
• Start date: October 15, 2010
• Est. completion date: October 15, 2019

Study information

• Verified date: April 2024
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The optimal interval between neoadjuvant chemradiotherapy and esophagectomy is still a question that needs to be explored for patients with esophageal squamous cell carcinoma. In this study, based on previous studies, the investigators divided patients into two groups with a cutoff value of 50 days. By comparing the overall survival and disease-free survival of the entire population and non PCR population, the investigators ultimately obtained the optimal surgical timing suitable for clinical use

Description:

background：Neoadjuvant chemoradiotherapy has gradually become a first-line treatment for esophageal squamous cell carcinoma patients. After the completion of neoadjuvant chemoradiotherapy, patients usually undergo minimally invasive surgery to ensure complete removal of the tumor and lymphatic tissue. However, the optimal interval between neoadjuvant chemoradiotherapy and minimally invasive surgery is still an unknown factor, and whether it affects postoperative disease-free survival (DFS) and overall survival (OS) of patients remains unknown. Therefore, the main purpose of this study is to explore the specific impact of the interval between neoadjuvant chemoradiotherapy and minimally invasive surgery on patients, and to find the optimal interval time.

methods：Patients who underwent neoadjuvant chemoradiotherapy and minimally invasive surgery from two institutions between October 2010 and September 2019 were included in this study. The time interval is defined as the days between the last time a patient receives neoadjuvant chemoradiotherapy and the execution of surgery. Based on past research, the interval between the two groups was determined to be 50 days. The main research result is the OS and DFS of different interval groups in the overall population and non-PCR population. A multivariate Cox regression model was established to determine the main factors affecting Patient's OS and DFS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• (I) thoracic ESCC

• (II) no history of concomitant or prior malignancy

• (III) Completed one cycle of nCRT

• (IV) Received endoscopic radical surgery for esophageal cancer

Exclusion Criteria:

• (I)other histological subtypes

• (II)Received ESD treatment

• (III) Radiation dose greater than 50Gy

• (IV) Metastatic esophageal squamous cell carcinoma

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Time

Intervention

Radiation:
• Neoadjuvant chemradiotherapy
Patients receiving neoadjuvant chemradiotherapy cause tumor shrinkage

Procedure:
• Minimally invasive esophagectomy
The patient underwent minimally invasive esophagectomy to remove residual tumors and surrounding lymph nodes

Locations

Country	Name	City	State
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (24)

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall survival of the overall population	Does the overall population survive	5 years
Primary	The Disease-Free survival of the overall population	Is there any tumor metastasis or recurrence in the overall population	5 years
Primary	The overall survival of the non-PCR population	Does the non-PCR population survive	5 years
Primary	The Disease-Free survival of the non-PCR population	Is there any tumor metastasis or recurrence in the non-PCR population	5 years
Primary	The overall survival of the PCR population	Does the PCR population survive	5 years
Primary	The Disease-Free survival of the PCR population	Is there any tumor metastasis or recurrence in the PCR population	5 years