Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma

Esophagus Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569668
• Other study ID #: HCH2101
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: October 2022
• Source: Henan Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 826
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophagus Cancer

Intervention

Drug:
• Paclitaxel- and platinum-based chemotherapy
Neoadjuvant Chemotherapy

Locations

Country	Name	City	State
China	Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OS(overall survival)	OS was defined as the first date of patient admission to the inpatient thoracic surgery department to the date of death from any cause.	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
Secondary	DFS(disease-free survival)	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.	From date of patient admission to the inpatient thoracic surgery department until the date of first documented progression, assessed up to 100 months