Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma

Completed

• Conditions: Esophagus Cancer
• Interventions: Drug: Paclitaxel- and platinum-based chemotherapy

• Registration Number: NCT05569668
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

Most ESCC received NAC in China without supportive evidence from local RCTs. The negative conclusion about NAC originated from Western countries in the 1990s. Whether two-field extensive mediastinal lymphadenectomy and paclitaxel/platinum-based chemotherapy results in better survival should be determined. As the highest ESCC incidence area worldwid, we tried to analyze this top with big data by using a single-center case-control retrospective PMS study. Paclitaxel- and platinum-based NAC combined with two-field of the extensive mediastinal lymphadenectomy might provide better survival benefits than primary esophagectomy for stage II/III SCC.

Detailed Description

Treatment Neoadjuvant Chemotherapy Standard NAC comprised 2 cycles. Platinum plus paclitaxel or docetaxel was repeated once every 3 weeks. Cis-platinum was administered at a total dose of 75 mg/m2 by continuous infusion on d1 or equal divided on Days 2-4 or Days 1-3. Paclitaxel, 175 mg/m2, d1, or paclitaxel, 87.5 mg/m2, d1, d8. If the docetaxel was adopted, it was given as 75 mg/m2 on Day 1.

Surgical Procedure At approximately 6-8 weeks after NAC, open (McKeown, left thoracic incision left cervical anastomosis) or MIE via thoracoscopy and/or laparoscopy was performed in the patients. Bilateral laryngeal recurrent nerve lymph node dissection was requested for every patient.

Comparisons between the NAC and primary surgery groups were performed using the chi-square test, Mann-Whitney U test and Fisher's exact test for categorical parameters after PMS. Kaplan-Meier curves and a Cox proportional hazards regression model were adopted to perform OS analysis.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-02
• Study First Submitted QC: 2022-10-05
• Last Update Submitted: 2022-10-05
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 826

Inclusion Criteria

• Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018 and the data was prospectively collected in the hubble of the LinkDoc data company
• Surgery performed in the thoracic surgery department
• No previous cancer treatment

Exclusion Criteria

• Patients with secondary cancer were excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary surgery group	Paclitaxel- and platinum-based chemotherapy	The patients would receive primary surgery----esophagectomy and two-field extensive mediastinal lymphadenectomy. After surgery, there might be a adjuvant chemotherayp for pathologically positive lymph nodes patients. .

Primary Outcome Measures

Name	Time	Method
OS(overall survival)	From date of patient admission to the inpatient thoracic surgery department until the date of first documented death from any cause, assessed up to 100 months	OS was defined as the first date of patient admission to the inpatient thoracic surgery department to the date of death from any cause.

Secondary Outcome Measures

Name	Time	Method
DFS(disease-free survival)	From date of patient admission to the inpatient thoracic surgery department until the date of first documented progression, assessed up to 100 months	DFS was defined as the first day of patients admission to the inpatient department to the date of tumor recurrence confirmed by the follow-up tests.

Trial Locations

Locations (1)

Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University); 🇨🇳 Zhengzhou, Henan, China