Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

Phase 4

Completed

• Conditions: Esophageal Cancer
• Interventions: Drug: Lobaplatin; Drug: Cisplatin

• Registration Number: NCT03413436
• Lead Sponsor: Henan Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Study Start: 2018-01-31
• Primary Completion: 2018-02-21
• Study Completion: 2018-02-21
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-26
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 733

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Lobaplatin group	Lobaplatin	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.
Cisplatin group	Cisplatin	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.

Primary Outcome Measures

Name	Time	Method
overall survival	5 years	The days from esophagectomy to cancer specific death

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university; 🇨🇳 ZhengZhou, Henan, China