Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

Sponsor

Henan Cancer Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03413436

Collaborator

(none)

733

Enrollment

Location

Arms

Actual Duration (Days)

1062.4

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Drug: Lobaplatin Drug: Cisplatin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

733 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 31, 2018

Actual Primary Completion Date :

Feb 21, 2018

Actual Study Completion Date :

Feb 21, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

overall survival [5 years]
The days from esophagectomy to cancer specific death

Secondary Outcome Measures

toxicities of adjuvant chemotherapy [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. thoracic ESCC stage II to III; ii) without any preoperation treatment for ESCC;

underwent R0 resection; iv) received ajuvant chemotherapy of Cisplatin plus Docetaxel or Lobaplatin plus Docetaxel.

Exclusion Criteria:

1. with ajuvant radiotherapy/chemoradiotherapy; ii) history of other type of cancer

without completed clinical, pathological and follow up data.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university	ZhengZhou	Henan	China	450008

Sponsors and Collaborators

Henan Cancer Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Henan Cancer Hospital

ClinicalTrials.gov Identifier:

NCT03413436

Other Study ID Numbers:

HenanCH1801

First Posted:

Jan 29, 2018

Last Update Posted:

Aug 28, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Henan Cancer Hospital

adjuvant chemotherapy

multicenter retrospective study

Additional relevant MeSH terms:

Esophageal Neoplasms

Cisplatin

Study Results

No Results Posted as of Aug 28, 2020