Definitive (Chemo)Radiotherapy for Patients With Esophageal Cancer - 3JECROG R-01

December 29, 2018 updated by: Zefen Xiao, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Multicenter Analysis of Definitive (Chemo)Radiotherapy With or Without Chemotherapy for Patients With Esophageal Cancer - 3JECROG-R01

The aim of this observational study is to retrospectively collect survival data for 3000 primary esophageal cancer patients from multicenter between January 2000 to present. Based on a Cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or without chemotherapy.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2762

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with esophageal or esophagogastric junction cancer

Description

Inclusion Criteria:

  • Histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction Unresectable or potentially resectable tumor (cT3-4N0-1M0-M1b, without visceral metastasis, according to AJCC 6th) based on standard primary staging by EUS and CT
  • Age>18 years
  • No distant metastasis other than supraclavicular lymph nodes
  • No prior history of thoracic radiation
  • Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,500 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits

Exclusion Criteria:

  • Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer during 5 years before diagnosis of esophageal cancer
  • Pregnant or lactating females
  • Contraindication for radiotherapy or chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Chemoradiotherapy
Chemoradiotherapy following chemotherapy
Chemoradiotherapy followed by chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 1 year
1 year
Overall survival
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Progress free survival
Time Frame: 1 year
1 year
Progress free survival
Time Frame: 2 year
2 year
Locoregional recurrence free survival
Time Frame: 1 year
1 year
Locoregional recurrence free survival
Time Frame: 2 year
2 year
Distant metastasis free survival
Time Frame: 1 year
1 year
Distant metastasis free survival
Time Frame: 2 year
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborators

The First Affiliated Hospital with Nanjing Medical University
Fujian Cancer Hospital
Tianjin Medical University Cancer Institute and Hospital
Beijing Hospital
Affiliated Hospital of Hebei University
Hebei Medical University Fourth Hospital
Anyang Tumor Hospital
Tengzhou Central People's Hospital
PLA Army General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

October 2, 2017

Study Record Updates

Last Update Posted (Actual)

January 2, 2019

Last Update Submitted That Met QC Criteria

December 29, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3JECROG R-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemoradiation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe