Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

733 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-02-21

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lobaplatin

Intervention Type DRUG

at least one cycle adjuvant chemotherapy after esophagectomy

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.

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

at least one cycle adjuvant chemotherapy after esophagectomy

Interventions

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Lobaplatin

at least one cycle adjuvant chemotherapy after esophagectomy

Intervention Type DRUG

Cisplatin

at least one cycle adjuvant chemotherapy after esophagectomy

Intervention Type DRUG

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No