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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03413436
Other study ID # HenanCH1801
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 31, 2018
Est. completion date February 21, 2018

Study information

Verified date August 2020
Source Henan Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 733
Est. completion date February 21, 2018
Est. primary completion date February 21, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lobaplatin
at least one cycle adjuvant chemotherapy after esophagectomy
Cisplatin
at least one cycle adjuvant chemotherapy after esophagectomy

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 overall survival The days from esophagectomy to cancer specific death 5 years
Secondary toxicities of adjuvant chemotherapy According to National Cancer Institute Common Terminology Criteria for Adverse Event,Version 3.0(CTC AE3.0). from chemotherapy to 3 month after last cycle adjuvant chemotherapy
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