Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

Henan Cancer Hospital733 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

733

Conditions

Esophageal Cancer

Interventions

LobaplatinDRUG

at least one cycle adjuvant chemotherapy after esophagectomy

CisplatinDRUG

at least one cycle adjuvant chemotherapy after esophagectomy

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * i) thoracic ESCC stage II to III; ii) without any preoperation treatment for ESCC; iii) underwent R0 resection; iv) received ajuvant chemotherapy of Cisplatin plus Docetaxel or Lobaplatin plus Docetaxel. Exclusion Criteria: * i) with ajuvant radiotherapy/chemoradiotherapy; ii) history of other type of cancer iii) without completed clinical, pathological and follow up data.

Locations (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, China

Outcomes

Primary Outcomes

overall survival

The days from esophagectomy to cancer specific death

Time frame: 5 years

Secondary Outcomes

toxicities of adjuvant chemotherapy

According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0).

Time frame: from chemotherapy to 3 month after last cycle adjuvant chemotherapy

Data from ClinicalTrials.gov

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