NCT05327517

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Apr 2022Dec 2028

First Submitted

Initial submission to the registry

April 7, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

April 10, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

6.7 years

First QC Date

April 7, 2022

Last Update Submit

April 7, 2022

Conditions

Cervical Esophageal Cancer

Keywords

Esophageal neoplasmChemoradiotherapyEsophagectomyOverall survival

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    5 year overall survival

    5 years after surgery or definitive Chemoradiotherapy is completed

Secondary Outcomes (1)

  • Laryngo-esophageal dysfunction free survival

    5 years after surgery or definitive Chemoradiotherapy is completed

Study Arms (2)

Surgery

EXPERIMENTAL

Patients receive esophagectomy or neoadjuvant therapy plus esophagectomy

Procedure: Esophagectomy

Definitive chemoradiotherapy

ACTIVE COMPARATOR

Patients receive definitive chemoradiotherapy

Procedure: Esophagectomy

Interventions

EsophagectomyPROCEDURE

Patients receive esophagectomy or definitive chemoradiotherapy according to patient preference

Also known as: Definitive chemoradiotherapy
Definitive chemoradiotherapySurgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jie He, MD

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

    STUDY DIRECTOR

  • Yin Li, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Wang, MD

CONTACT

+8613600892432wangzhen@cicams.ac.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2022

First Posted

April 14, 2022

Study Start

April 10, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
expected to be shared as an article paper after the trial ends

Locations

CN(1)