Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413436
• Other study ID #: HenanCH1801
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

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