- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413436
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
-
-
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.
|
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.
|
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
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.
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
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.
Clinical Trials on Esophageal Cancer
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OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnStage IIB Esophageal Cancer AJCC v7 | Stage III Esophageal Cancer AJCC v7 | Stage IIIA Esophageal Cancer AJCC v7 | Stage IIIB Esophageal Cancer AJCC v7 | Stage IIIC Esophageal Cancer AJCC v7
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