Report of the Survival Outcomes of Patients With Esophageal Cancer After Definitive Radiotherapy in China

Esophageal Neoplasms Clinical Trial

Official title:

Report of the Survival Outcomes of Patients With Esophageal Cancer After Definitive Radiotherapy in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194371
• Other study ID #: YW2021-92-1
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: January 2022
• Source: Chinese Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, data of esophageal cancer patients undergoing definitive radiotherapy in 14 institutions from various provinces in China were evaluated to help strengthen confidence in anti-cancer, including rehabilitation, economic burden, and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: December 15, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with esophageal cancer who received definitive radiotherapy (radiotherapy dose =50Gy) from 2015 to 2016

2. Age = 18

3. The radiation field included primary esophageal tumor with or without lymph node metastasis

Exclusion Criteria:

1. Radiotherapy dose < 50Gy

2. Palliative radiotherapy

3. The radiation field are metastatic areas, such as bone, brain, adrenal gland, isolated metastatic lymph nodes, etc

Related Conditions & MeSH terms

• Esophageal Neoplasms

Intervention

Radiation:
• definitive radiotherapy or definitive chemoradiotherapy
A total dose of radiation therapy should be more than 50Gy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		5 year
Secondary	the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess quality of life (QOL)	The EORTC QLQ-core 30 questionnaire is composed of multi-item scales and single-item measures including 5 functional scales, 3 symptom scales, a global health status-QoL scale, and 6 single items. Each of the multi-item scales includes a different set of items - no item occurs in more than 1 scale. High scale score=higher response level; a high score for a functional scale=a healthy level of function, high score for the global health status/QoL=high quality of life but a high score for a symptom scale / item=high level of symptomatology/problems. The principle for scoring these scales: 1.) Estimate the average of the items that contribute to the scale = raw score. 2.) Linear transformation to standardize the raw score, so that scores range from 0 to 100. Results should be interpreted with caution as the numbers of patients with available data over time were limited, and because of high variances as evidenced by large standard deviations.	5 year
Secondary	Costs of treatment	Financial burden, Whether medical insurance is affordable	5 year
Secondary	Proportion of using chemotherapy or target therapy concurrently with radiotherapy	Medication	2 month