Lobaplation or Cisplatin in Adjuvant Chemotherapy for Esophageal Carcinoma

NCT03413436 | Completed Phase 4 DMC

• 1 other identifier: HenanCH1801
• Study Type: interventional
• Target: 733
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Cancer

Keywords

adjuvant chemotherapy; multicenter retrospective study

Outcome Measures

Primary Outcomes (1)

• overall survival

  The days from esophagectomy to cancer specific death

  5 years

Secondary Outcomes (1)

• toxicities of adjuvant chemotherapy

  from chemotherapy to 3 month after last cycle adjuvant chemotherapy

Study Arms (2)

Lobaplatin group

EXPERIMENTAL

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

Cisplatin group

ACTIVE COMPARATOR

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

Interventions

Lobaplatin DRUG

at least one cycle adjuvant chemotherapy after esophagectomy

Lobaplatin group

Cisplatin DRUG

at least one cycle adjuvant chemotherapy after esophagectomy

Cisplatin group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• i) with ajuvant radiotherapy/chemoradiotherapy; ii) history of other type of cancer iii) without completed clinical, pathological and follow up data.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

Study Sites (1)

Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university

Zhengzhou, Henan, 450008, China

Location

Related Publications (1)

• 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.

  PMID: 34589419 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

lobaplatin; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Yin Li, Dr.

  The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: January 31, 2018
• Primary Completion: February 21, 2018
• Study Completion: February 21, 2018
• Last Updated: August 28, 2020

Record last verified: 2020-08

Locations

CN (1)