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

Completed

• Conditions: Esophageal Neoplasms
• Interventions: Radiation: definitive radiotherapy or definitive chemoradiotherapy

• Registration Number: NCT05194371
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-15
• Study First Submitted: 2021-12-24
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-14
• Last Update Submitted: 2022-01-14
• Study First Posted: 2022-01-18
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Definitive (chemo)radiotherapy	definitive radiotherapy or definitive chemoradiotherapy	-

Primary Outcome Measures

Name	Time	Method
Overall survival	5 year

Secondary Outcome Measures

Name	Time	Method
the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess quality of life (QOL)	5 year	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.
Proportion of using chemotherapy or target therapy concurrently with radiotherapy	2 month	Medication
Costs of treatment	5 year	Financial burden, Whether medical insurance is affordable

Trial Locations

Locations (1)

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, China