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

NCT ID: NCT03298204

Last Updated: 2019-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2762 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Esophagus Cancer Chemoradiation Chemotherapy Effect Radiotherapy Side Effect

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Chemoradiotherapy

No interventions assigned to this group

Chemoradiotherapy following chemotherapy

No interventions assigned to this group

Chemoradiotherapy followed by chemotherapy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University Fourth Hospital

OTHER

Sponsor Role collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role collaborator

Anyang Tumor Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Affiliated Hospital of Hebei University

OTHER

Sponsor Role collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role collaborator

Tengzhou Central People's Hospital

OTHER_GOV

Sponsor Role collaborator

PLA Army General Hospital

UNKNOWN

Sponsor Role collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zefen Xiao

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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3JECROG R-01

Identifier Type: -

Identifier Source: org_study_id

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