Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）

NCT04027543 | Completed DMC FDA Drug

• 1 other identifier: SYSEC-KY-KS-2019-068
• Study Type: observational
• Target: 423
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Radiotherapy Side Effect; Chemotherapy Effect; Oesophageal Carcinoma; Effect of Drugs; Safety Issues

Keywords

Neoadjuvant chemoradiotherapy; Neoadjuvant chemotherapy; Resectable oesophageal carcinoma; Effective; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease-free survival (DFS)

  5 years

• R0 resection rate

  Baseline

• Pathologic complete response (pCR)

  Baseline

• 30-day postoperative or in-hospital mortality

  30 days

Study Arms (3)

Neoadjuvant chemoradiotherapy

Patients who had chemoradiotherapy before surgery.

Combination Product: Neoadjuvant chemoradiotherapy

Neoadjuvant chemotherapy

Patients who had chemotherapy before surgery.

Drug: Neoadjuvant chemotherapy

Surgery alone

Patients who only had oesophagectomy. Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic. The appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.

Procedure: Oesophagectomy

Interventions

Neoadjuvant chemoradiotherapy COMBINATION_PRODUCT

In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

Neoadjuvant chemoradiotherapy

Oesophagectomy PROCEDURE

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.

Surgery alone

Neoadjuvant chemotherapy DRUG

In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.

Neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• Guangdong Provincial People's Hospital: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (3)

Massachusetts General Hospital of Harvard Medical School

Boston, Massachusetts, 01748, United States

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Related Publications (1)

• 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.

  PMID: 32637899 DERIVED

MeSH Terms

Conditions

Radiation Injuries; Esophageal Neoplasms

Interventions

Neoadjuvant Therapy; Esophagectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Herui Yao, PhD

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

• Haiyu Zhou, PhD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

• Michael Lanuti, PhD

  Massachusetts General Hospital of Harvard Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 22, 2019
• Study Start: November 14, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CN (2)