NCT03413436

Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

Multicenter Comparative of Toxicity and Effectiveness of Lobaplation or Cisplatin Based Adjuvant Chemotherapy in Esophageal Carcinoma

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 733 (actual)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The multicenter real-world and propensity score matching comparative study was designed to explore the toxicity and effectiveness of Lobaplation or Cisplatin based adjuvant chemotherapy in esophageal carcinoma

Detailed description

This trial is a multicenter real-world retrospective comparative study. The patients with thoracic esophageal squamous cell carcinoma, esophagectomy and adjuvant chemotherapy(Cisplatin plus Docetaxel or Lobaplatin plus Docetaxel) from 6 centers in China were enrolled from Jan.2013 to Dec.2016. Completed clinical and pathological data were collected from Large-scale Data Analysis Center of Cancer Precision Medicine-LinkDoc database and analyzed by using data technology support from LinkDoc by using R-language. A hybrid solution for extracting structured medical infromation from unstructured data in medical records via a double-reading/entry system. The World Health Organization (Toxicity Grading Scale for Determining the Severity of Adverse Events) was used. The side effects of adjuvant chemotherapy and overall survival rate were compared by a propensity score. The 6 centers are The affiliated Cancer Hospital of ZhengZhou university/Henan Cancer Hospital, Anyang Cancer Hospital, Anhui Province Hospital, The first affiliated Hospital of Anhui university, Tangdu Hospital/the affiliated Hospital of Fourth Military Medical University, The First Affiliated Hospital of Xi'an Jiao Tong University.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Lobaplatin	at least one cycle adjuvant chemotherapy after esophagectomy
DRUG	Cisplatin	at least one cycle adjuvant chemotherapy after esophagectomy

Timeline

• Start date: 2018-01-31
• Primary completion: 2018-02-21
• Completion: 2018-02-21
• First posted: 2018-01-29
• Last updated: 2020-08-28

Locations

1 site across 1 country: China