Clinical trial NCT03413436: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esophageal Cancer
Keywords: adjuvant chemotherapy
multicenter retrospective study
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2018-01-29
Enrollment: 733
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: toxicities of adjuvant chemotherapy
timeFrame: from chemotherapy to 3 month after last cycle adjuvant chemotherapy
Other outcomes:
Locations:
city: ZhengZhou
country: China
facility: Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
state: Henan
Study officials:
affiliation: The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
name: Yin Li, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.