Safety Issues Clinical Trial
Official title:
Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)
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 |
To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guangdong Provincial People's Hospital, Massachusetts General Hospital |
United States, China,
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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