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OpenTrials
Completed

NCT Number: NCT05194371

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

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.

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Key information

Conditions

Esophageal Neoplasms Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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, 100021, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with esophageal cancer who received definitive radiotherapy (radiotherapy dose ≥50Gy) from 2015 to 2016
  • Age ≥ 18
  • The radiation field included primary esophageal tumor with or without lymph node metastasis

Exclusion criteria

  • Radiotherapy dose < 50Gy
  • Palliative radiotherapy
  • The radiation field are metastatic areas, such as bone, brain, adrenal gland, isolated metastatic lymph nodes, etc

Treatment and study plan

definitive radiotherapy or definitive chemoradiotherapy

Radiation

A total dose of radiation therapy should be more than 50Gy

Primary outcomes

  1. Overall survival

    Time frame: 5 year

Secondary outcomes

  1. the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess quality of life (QOL)

    Time frame: 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.

  2. Costs of treatment

    Time frame: 5 year

    Financial burden, Whether medical insurance is affordable

  3. Proportion of using chemotherapy or target therapy concurrently with radiotherapy

    Time frame: 2 month

    Medication

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 18, 2022
Registry last updated
Jan 18, 2022

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.

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