Esophageal NeoplasmsNCT05194371
Report of the Survival Outcomes of Patients With Esophageal Cancer After Definitive Radiotherapy in China
An observational study of Esophageal Neoplasms, run by Chinese Academy of Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms
- What is being tested?
- definitive radiotherapy or definitive chemoradiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 15 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with esophageal cancer who received definitive radiotherapy (radiotherapy dose ≥50Gy) from 2015 to 2016 in 14 institutions in China
Who may be able to join
- 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
Who cannot join
- Radiotherapy dose < 50Gy
- Palliative radiotherapy
- The radiation field are metastatic areas, such as bone, brain, adrenal gland, isolated metastatic lymph nodes, etc
Trial locations and contacts
1 site in 1 country.
China1 site
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
About this study
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.
- Conditions
- Esophageal Neoplasms
- Being tested
- definitive radiotherapy or definitive chemoradiotherapy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
definitive radiotherapy or definitive chemoradiotherapyRadiation
A total dose of radiation therapy should be more than 50Gy
| Study group | Role | What they receive |
|---|---|---|
| Definitive (chemo)radiotherapy | Not described Receives: Radiation: definitive radiotherapy or definitive chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 5 year
Secondary outcomes (3)
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.
Measured: 5 year
Costs of treatment
Financial burden, Whether medical insurance is affordable
Measured: 5 year
Proportion of using chemotherapy or target therapy concurrently with radiotherapy
Medication
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Jun 2021
- Primary completion31 Oct 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luhua Wang, Chinese Academy of Medical Sciences
- Investigators
- Lvhua Wang, Principal investigator, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union MedicKuaile Zhao, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194371
- Sponsor's protocol ID
- YW2021-92-1
- Status last verified
- Jan 2022
- First submitted
- 24 Dec 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Report of the Survival Outcomes of Patients With Esophageal Cancer After Definitive Radiotherapy in China
- ClinicalTrials.gov ID
- NCT05194371
- Acronym / sponsor ID
- YW2021-92-1
- Conditions
- Esophageal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Definitive (chemo)radiotherapy | – | Radiation: definitive radiotherapy or definitive chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal cancer who received definitive radiotherapy (radiotherapy dose ≥50Gy) from 2015 to 2016 in 14 institutions in China
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Radiotherapy dose < 50Gy
- Palliative radiotherapy
- The radiation field are metastatic areas, such as bone, brain, adrenal gland, isolated metastatic lymph nodes, etc
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| definitive radiotherapy or definitive chemoradiotherapyA total dose of radiation therapy should be more than 50Gy | Radiation | Definitive (chemo)radiotherapy |
Primary outcome
Overall survival
Time frame: 5 year
3 secondary outcomes
the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess quality of life (QOL)
Time frame: 5 year
Costs of treatment
Time frame: 5 year
Proportion of using chemotherapy or target therapy concurrently with radiotherapy
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lvhua Wang principal investigator
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medic
Kuaile Zhao principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Neoplasms, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.