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Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

Primary Purpose

Cervical Esophageal Cancer

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Esophagectomy

About this trial

This is an interventional treatment trial for Cervical Esophageal Cancer focused on measuring Esophageal neoplasm, Chemoradiotherapy, Esophagectomy, Overall survival

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0);
Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included;
Aged 18-75 years;
Without any contraindication of operation;
Hemoglobin >=90 g/L; Leukocytes >=4.0x10^9/L; Absolute neutrophil count >=1.5x10^9/L; Platelet >=100x10^9/L;Total bilirubin <=1.5 ULN; ALT <=2.5 ULN; AST <=2.5 ULN; Serum creatinine <=1.5 ULN or creatinine clearance rate >=50 mL/min (Cocheroft-Gault);INR <=1.5 ULN; APTT <=1.5 ULN;
Without other malignancies;
Expected R0 resection;
ECOG PS 0-1;
Volunteered to participate in the study, signed the informed consent form.

Exclusion Criteria:

Without other malignancies;
With mental diseases;
With hemorrhagic disease;
Inoperable patients;
Pregnant or lactating women;
Has a history of allergy to paclitaxel or cisplatin

Sites / Locations

Cancer Hospital Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Surgery

Definitive chemoradiotherapy

Arm Description

Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy

Patients receive definitive chemoradiotherapy

Outcomes

Primary Outcome Measures

Overall Survival

5 year overall survival

Secondary Outcome Measures

Laryngo-esophageal dysfunction free survival

5 year laryngo-esophageal dysfunction free survival

Full Information

NCT ID

NCT05327517

First Posted

April 7, 2022

Last Updated

April 7, 2022

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT05327517

Brief Title

Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

Official Title

Surgery Versus Definitive Chemoradiotherapy for Resectable Cervical Esophageal Squamous Cell Carcinoma: A Prospective Multicenter Open-Label Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 10, 2022 (Anticipated)

Primary Completion Date

December 31, 2028 (Anticipated)

Study Completion Date

December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To compare surgery with definitive chemoradiotherapy for patients with resectable cervical esophageal squamous cell carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Esophageal Cancer

Keywords

Esophageal neoplasm, Chemoradiotherapy, Esophagectomy, Overall survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

192 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surgery

Arm Type

Experimental

Arm Description

Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy

Arm Title

Definitive chemoradiotherapy

Arm Type

Active Comparator

Arm Description

Patients receive definitive chemoradiotherapy

Intervention Type

Procedure

Intervention Name(s)

Esophagectomy

Other Intervention Name(s)

Definitive chemoradiotherapy

Intervention Description

Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference

Primary Outcome Measure Information:

Title

Overall Survival

Description

5 year overall survival

Time Frame

5 years after surgery or definitive Chemoradiotherapy is completed

Secondary Outcome Measure Information:

Title

Laryngo-esophageal dysfunction free survival

Description

5 year laryngo-esophageal dysfunction free survival

Time Frame

5 years after surgery or definitive Chemoradiotherapy is completed

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with resectable cervical esophageal squamous cell carcinoma (cT1b-T4aN0-3M0); Cervical esophageal cancers spreads upwards to involve the hypopharynx and downwards to involve the thoracic esophagus can also be included; Aged 18-75 years; Without any contraindication of operation; Hemoglobin >=90 g/L; Leukocytes >=4.0x10^9/L; Absolute neutrophil count >=1.5x10^9/L; Platelet >=100x10^9/L;Total bilirubin <=1.5 ULN; ALT <=2.5 ULN; AST <=2.5 ULN; Serum creatinine <=1.5 ULN or creatinine clearance rate >=50 mL/min (Cocheroft-Gault);INR <=1.5 ULN; APTT <=1.5 ULN; Without other malignancies; Expected R0 resection; ECOG PS 0-1; Volunteered to participate in the study, signed the informed consent form. Exclusion Criteria: Without other malignancies; With mental diseases; With hemorrhagic disease; Inoperable patients; Pregnant or lactating women; Has a history of allergy to paclitaxel or cisplatin

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhen Wang, MD

Phone

+8613600892432

wangzhen@cicams.ac.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jie He, MD

Organizational Affiliation

Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Yin Li, MD

Organizational Affiliation

Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital Chinese Academy of Medical Sciences

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yin Li, MD

Phone

861087788052

liyin@cicams.ac.cn

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

expected to be shared as an article paper after the trial ends

IPD Sharing Time Frame

expected to be shared as an article paper after the trial ends

Learn more about this trial

Surgery or Chemoradiotherapy for Cervical Esophageal Cancer

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