Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma

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.

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Key information

Conditions

Esophagus Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Observational

Primary location

Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)

Zhengzhou, Henan, 450003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Paclitaxel- and platinum-based chemotherapy

Drug

Neoadjuvant Chemotherapy

Primary outcomes

OS(overall survival)

Time frame: 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 outcomes

DFS(disease-free survival)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Oct 6, 2022
Registry last updated: Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed