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Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

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ClinicalTrials.gov Identifier: NCT03413436
Recruitment Status : Not yet recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 731 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
Estimated Study Start Date : January 31, 2018
Estimated Primary Completion Date : February 21, 2018
Estimated Study Completion Date : February 21, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

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




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    The days from esophagectomy to cancer specific death


Secondary Outcome Measures :
  1. toxicities of adjuvant chemotherapy [ Time Frame: 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413436


Contacts
Contact: Yin Li, Dr. +8613903838752 liyin825@aliyun.com
Contact: Yan Zheng, Dr. +8615713660065 sunnyzheng1@126.com

Locations
China, Henan
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

Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03413436     History of Changes
Other Study ID Numbers: HenanCH1801
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Henan Cancer Hospital:
adjuvant chemotherapy
multicenter retrospective study

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Antineoplastic Agents