NCT05569668

Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma

Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma: A Missing Evidence and A Retrospective Case-control Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 826 (actual)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Esophagus Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel- and platinum-based chemotherapy	Neoadjuvant Chemotherapy

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2022-10-06
• Last updated: 2022-10-06

Locations

1 site across 1 country: China