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

Chemotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03298204
• Other study ID #: 3JECROG R-01
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: December 2018
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2762
• Est. completion date: February 28, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemoradiation
• Chemotherapy Effect
• Esophageal Neoplasms
• Esophagus Cancer
• Radiotherapy Side Effect

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)	Beijing

Sponsors (10)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Affiliated Hospital of Hebei University, Anyang Tumor Hospital, Beijing Hospital, Fujian Cancer Hospital, Hebei Medical University Fourth Hospital, PLA Army General Hospital, Tengzhou Central People's Hospital, The First Affiliated Hospital with Nanjing Medical University, Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		1 year
Primary	Overall survival		2 year
Secondary	Progress free survival		1 year
Secondary	Progress free survival		2 year
Secondary	Locoregional recurrence free survival		1 year
Secondary	Locoregional recurrence free survival		2 year
Secondary	Distant metastasis free survival		1 year
Secondary	Distant metastasis free survival		2 year