Clinical trial NCT05569668: Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma
Official title: Neoadjuvant Chemotherapy Compared With Surgery for Esophageal Carcinoma: A Missing Evidence and A Retrospective Case-control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophagus Cancer
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-06
Enrollment: 826
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical diagnosis of Esophageal Squamous Cell Carcinoma(ESCC) at Henan Cancer Hospital between January 1, 2015, and December 31, 2018

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.

Eligibility criteria: 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

Primary outcomes:
measure: OS(overall survival)
timeFrame: 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 outcomes:
measure: DFS(disease-free survival)
timeFrame: From date of patient admission to the inpatient thoracic surgery department until the date of first documented progression, assessed up to 100 months
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
state: Henan
Study officials:
affiliation: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
name: Yan Zheng, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: