Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

August 26, 2020 updated by: Henan Cancer Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

733

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • ZhengZhou, Henan, China, 450008
        • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lobaplatin group
i) thoracic ESCC stage II to III; ii) without any preoperation treatment for ESCC; iii) underwent R0 resection; iv) received at least one cycle ajuvant chemotherapy of Lobaplatin plus Docetaxel; v) without ajuvant radiotherapy/chemoradiotherapy; vi) without history of other type of cancer. Completed clinical, pathological and follow up data.
Drug: Lobaplatin
at least one cycle adjuvant chemotherapy after esophagectomy
Active Comparator: Cisplatin group
i) thoracic ESCC stage II to III; ii) without any preoperation treatment for ESCC; iii) underwent R0 resection; iv) received at least one cycle ajuvant chemotherapy of Cisplatin plus Docetaxel; v) without ajuvant radiotherapy/chemoradiotherapy; vi) without history of other type of cancer. Completed clinical, pathological and follow up data.
Drug: Cisplatin
at least one cycle adjuvant chemotherapy after esophagectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years
The days from esophagectomy to cancer specific death
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
toxicities of adjuvant chemotherapy
Time Frame: from chemotherapy to 3 month after last cycle 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Cancer Hospital

Investigators

  • Principal Investigator: Yin Li, Dr., The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2018

Primary Completion (Actual)

February 21, 2018

Study Completion (Actual)

February 21, 2018

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

January 22, 2018

First Posted (Actual)

January 29, 2018

Study Record Updates

Last Update Posted (Actual)

August 28, 2020

Last Update Submitted That Met QC Criteria

August 26, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanCH1801

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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