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

NCT03298204 | Completed DMC

• 1 other identifier: 3JECROG R-01
• Study Type: observational
• Target: 2,762
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophagus Cancer; Chemoradiation; Chemotherapy Effect; Radiotherapy Side Effect

Outcome Measures

Primary Outcomes (2)

• Overall survival

  1 year

• Overall survival

  2 year

Secondary Outcomes (6)

• Progress free survival

  1 year

• Progress free survival

  2 year

• Locoregional recurrence free survival

  1 year

• Locoregional recurrence free survival

  2 year

• Distant metastasis free survival

  1 year

Study Arms (3)

Chemoradiotherapy

Chemoradiotherapy following chemotherapy

Chemoradiotherapy followed by chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with esophageal or esophagogastric junction cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Hebei Medical University Fourth Hospital: collaborator
• Fujian Cancer Hospital: collaborator
• Anyang Tumor Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Affiliated Hospital of Hebei University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Beijing Hospital: collaborator
• Tengzhou Central People's Hospital: collaborator
• PLA Army General Hospital: collaborator

Study Sites (1)

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

Beijing, 100021, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 2, 2017
• Study Start: June 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: February 28, 2018
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

CN (1)