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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04027543
Other study ID # SYSEC-KY-KS-2019-068
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 14, 2018
Est. completion date December 1, 2019

Study information

Verified date May 2020
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.


Description:

Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.


Recruitment information / eligibility

Status Completed
Enrollment 423
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction.

- Patients clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography.

- Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria:

- Patients had received any previous treatment for oesophageal cancer.

- Patients who were unsuitable for surgery because of comorbidities.

- Patients had evidence of distant metastatic disease by history and physical examination.

Study Design


Intervention

Combination Product:
Neoadjuvant chemoradiotherapy
In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
Procedure:
Oesophagectomy
Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.
Drug:
Neoadjuvant chemotherapy
In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

Locations

Country Name City State
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Sun Yat-Sen Memorial Hospital of Sun Yat-sen University Guangzhou Guangdong
United States Massachusetts General Hospital of Harvard Medical School Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Guangdong Provincial People's Hospital, Massachusetts General Hospital

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) The OS was calculated as the time from the date of the histologically documented diagnosis to the date of death or the final follow-up. 5 years
Secondary Disease-free survival (DFS) DFS was calculated from the date of R0 resection to the date of disease recurrence or death from any cause 5 years
Secondary R0 resection rate R0 resection was defined as gross disease removed with negative margins (tumour-free resection margin). Baseline
Secondary Pathologic complete response (pCR) pCR was defined as no evidence of residual tumour cells in the primary site and resected lymph nodes of the operative specimens. Baseline
Secondary 30-day postoperative or in-hospital mortality 30 days
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