Skip to main content
OpenTrials
Completed

NCT Number: NCT03298204

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Esophagus Cancer Chemoradiation Chemotherapy Effect Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Radiotherapy Side Effect Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Beijing, 100021, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 1 year

  2. Overall survival

    Time frame: 2 year

Secondary outcomes

  1. Progress free survival

    Time frame: 1 year

  2. Progress free survival

    Time frame: 2 year

  3. Locoregional recurrence free survival

    Time frame: 1 year

  4. Locoregional recurrence free survival

    Time frame: 2 year

  5. Distant metastasis free survival

    Time frame: 1 year

  6. Distant metastasis free survival

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 2, 2017
Registry last updated
Jan 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.