Status:
COMPLETED
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsors:
Guangdong Provincial People's Hospital
Massachusetts General Hospital
Conditions:
Radiotherapy Side Effect
Chemotherapy Effect
Eligibility:
All Genders
18-80 years
Brief Summary
To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 14 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT04027543
Start Date
November 14 2018
End Date
December 1 2019
Last Update
May 29 2020
Active Locations (3)
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1
Massachusetts General Hospital of Harvard Medical School
Boston, Massachusetts, United States, 01748
2
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
3
Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000