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Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lobaplatin
Cisplatin
Sponsored by
Henan Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adjuvant chemotherapy, multicenter retrospective study

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lobaplatin group

Cisplatin group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

overall survival
The days from esophagectomy to cancer specific death

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2018
Last Updated
August 26, 2020
Sponsor
Henan Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03413436
Brief Title
Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma
Official Title
Multicenter Comparative of Toxicity and Effectiveness of Lobaplation or Cisplatin Based Adjuvant Chemotherapy in Esophageal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
February 21, 2018 (Actual)
Study Completion Date
February 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
adjuvant chemotherapy, multicenter retrospective study

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
733 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lobaplatin group
Arm Type
Experimental
Arm Description
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.
Arm Title
Cisplatin group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lobaplatin
Intervention Description
at least one cycle adjuvant chemotherapy after esophagectomy
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
at least one cycle adjuvant chemotherapy after esophagectomy
Primary Outcome Measure Information:
Title
overall survival
Description
The days from esophagectomy to cancer specific death
Time Frame
5 years
Secondary Outcome Measure Information:
Title
toxicities of adjuvant chemotherapy
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin Li, Dr.
Organizational Affiliation
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
City
ZhengZhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34589419
Citation
Zheng Y, Li Y, Liu X, Sun H, Liang G, Hu J, Li L, Xing W. Multicentre Comparison of the Toxicity and Effectiveness of Lobaplatin-Based Versus Cisplatin-Based Adjuvant Chemotherapy in Oesophageal Carcinoma. Front Oncol. 2021 Sep 13;11:668140. doi: 10.3389/fonc.2021.668140. eCollection 2021.
Results Reference
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Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

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