Clinical trial NCT04027543: Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）
Official title: Clinical Evidence for Association of Neoadjuvant Chemotherapy or Chemoradiotherapy With Efficacy and Safety in Patients With Resectable Esophageal Carcinoma (NewEC Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiotherapy Side Effect
Chemotherapy Effect
Oesophageal Carcinoma
Effect of Drugs
Safety Issues
Keywords: Neoadjuvant chemoradiotherapy
Neoadjuvant chemotherapy
Resectable oesophageal carcinoma
Effective
Safety
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangdong Provincial People's Hospital
name: Massachusetts General Hospital
First posted: 2019-07-22
Enrollment: 423
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction that was 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 were eligible.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
measure: Disease-free survival (DFS)
timeFrame: 5 years
measure: R0 resection rate
timeFrame: Baseline
measure: Pathologic complete response (pCR)
timeFrame: Baseline
measure: 30-day postoperative or in-hospital mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital of Harvard Medical School
state: Massachusetts
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Herui Yao, PhD
role: STUDY_CHAIR
affiliation: Guangdong Provincial People's Hospital
name: Haiyu Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital of Harvard Medical School
name: Michael Lanuti, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhou HY, Zheng SP, Li AL, Gao QL, Ou QY, Chen YJ, Wu ST, Lin DG, Liu SB, Huang LY, Li FS, Zhu HY, Qiao GB, Lanuti M, Yao HR, Yu YF. Clinical evidence for association of neoadjuvant chemotherapy or chemoradiotherapy with efficacy and safety in patients with resectable esophageal carcinoma (NewEC study). EClinicalMedicine. 2020 Jun 27;24:100422. doi: 10.1016/j.eclinm.2020.100422. eCollection 2020 Jul.