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

Completed

• Conditions: Esophagus Cancer; Radiotherapy Side Effect; Chemoradiation; Chemotherapy Effect

• Registration Number: NCT03298204
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

Not available

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-09-27
• Primary Completion: 2017-09-30
• Study First Posted: 2017-10-02
• Study Completion: 2018-02-28
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-29
• Last Update Posted: 2019-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2762

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	2 year

Secondary Outcome Measures

Name	Time	Method
Progress free survival	2 year
Distant metastasis free survival	2 year
Locoregional recurrence free survival	2 year

Trial Locations

Locations (1)

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