Esophageal NeoplasmNCT06481449
Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study
An observational study of Esophageal Neoplasm, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
Cervical and upper thoracic esophageal cancer (ESCA) presents treatment challenges due to limited clinical evidence. This multi-center study (ChC\&UES) explores radical radio(chemo)therapy efficacy and safety Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasm
- How many people
- 2,600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2000to 1 Dec 2024
- 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: This study is a real-world study. All esophageal cancer patients over 18 years old who received radical radiotherapy in cervical and upper thoracic segment eligible for inclusion were retrospectively collected. This study is a reflection of real-world, no restriction on treatment was made.
Who may be able to join
- Age 18 and older.
- Confirmation of esophageal cancer through histopathology or cytology.
- Primary tumor location within the cervical or upper thoracic segment, extending from the upper esophageal sphincter to the azygos vein.
- Absence of distant metastasis.
- Patients unable or unwilling to undergo surgical treatment for various reasons.
- Receipt of radical radiotherapy as the first-line treatment, with or without chemotherapy, immunotherapy, or targeted therapy.
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- Undergoing conventional radiation therapy (1.8-2.0Gy per session, once per day).
- Receiving 3DCRT or IMRT radiotherapy.
- Availability of complete radiotherapy prescription dose information and follow-up records.
Who cannot join
- Receipt of radiation dose below 50Gy.
- History of other malignancies (except for cured cancer in situ and malignancies cured for over 5 years) or laryngeal invasion.
- Diagnosis of double primary esophageal cancer.
- Prior chest radiation therapy within the past 5 years.
- Recurrent or metastatic esophageal cancer.
- Receipt of 2D radiotherapy, large fractionation, or hyper-fractionation radiotherapy.
- Patients with incomplete radiotherapy dose and follow-up data.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Because this study is a response to real-world patient treatment and outcomes
Shijiazhuang, Hebei, 050000
Wenbin Shen, 8615831183879, wbshen2024@hebmu.edu.cn
About this study
Cervical and upper thoracic esophageal cancer (ESCA) presents treatment challenges due to limited clinical evidence. This multi-center study (ChC\&UES) explores radical radio(chemo)therapy efficacy and safety
Read the detailed description
Cervical and upper thoracic esophageal cancer (ESCA) are relatively rare diseases, presenting treatment challenges due to limited clinical evidence. This multi-center study (ChC\&UES) explores radical radiotherapy efficacy and safety, especially focusing on radiation dose. This study collected all eligible patients diagnosed with cervical and upper thoracic ESCA from 6 medical centers (Tianjin Cancer Hospital, Cancer Hospital of the Chinese Academy of Medical Sciences, Fujian Cancer Hospital, Fudan University Shanghai Cancer Center, Shandong Cancer Hospital and the Fourth Hospital of Hebei Medical University) in China. Patients were categoried into two group (low dose radiation group and high dose radiation group) based on radiation dose. Basic clinical information, including age, gender, ECOG score, pathological type, smoking and drinking history, initial visit date, radiotherapy dose, radiotherapy method, concurrent chemotherapy modality, immunotherapy, targeted drug usage, treatment efficacy assessment, toxicity and side effects and survival time was collected. Kaplan-Meier method was used to calculate OS, survival differences were assessed using the log-rank test. Univariate analysis was conducted via Cox regression modeling, with variables demonstrating P values < 0.1 being included in multivariate analysis. A significance level of two-sided P < 0.05 was considered statistically significant. The aim of this study was to compared the overall survival time between low dose radiation group and high dose radiation dose group and compared the underlying side effects.
- Conditions
- Esophageal Neoplasm
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High dose radiotherapy (≥60Gy) | Patients who received 60 Gy or more than 60Gy radiation dose for radical radiation therapy for the primary tumor. | |
| Low dose radiotherapy (50-<60Gy) | Patients who received 50-<60Gy radiation dose for radical radiation therapy for the primary tumor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time (OS)
Compared the differences in overall survival (OS) between low dose radiation and high dose radiation group after definitive radiotherapy. OS is defined as time from start of enrollment to death from any cause.
Measured: 2000.1.1-2024.6.20
progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the start of enrollment until tumor progression or death from any cause.
Measured: 2000.1.1-2024.6.20
Secondary outcomes (1)
Objective response rate (ORR)
The Objective Response Rate (ORR) is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Measures the effectiveness of a cancer treatment by showing the percentage of patients whose tumors shrink significantly within a specified time. ORR includes: Complete Response (CR): All target tumors disappear, and no new tumors appear.Partial Response (PR): The size of target tumors decreases by at least 30%, and no new tumors appear. The proportion of patients who achieve CR+PR was ORR.
Measured: 2000.1.1-2024.6.20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jan 2000
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- 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
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fujian Cancer Hospital, Fudan University, Shandong Cancer Hospital and Institute
- Responsible party
- Sponsor
- Investigators
- Wenbin Shen, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481449
- Sponsor's protocol ID
- 2024KY155
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definitive Radiotherapy for Cervical and Upper Thoracic Esophageal Cancer (ChC&UES): A Multi-center Real World Study
- ClinicalTrials.gov ID
- NCT06481449
- Acronym / sponsor ID
- 2024KY155
- Conditions
- Esophageal Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Collaborators
- Tianjin Medical University Cancer Institute and Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fujian Cancer Hospital, Fudan University, Shandong Cancer Hospital and Institute
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 Jul 2024 (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.
Cervical and upper thoracic esophageal cancer (ESCA) presents treatment challenges due to limited clinical evidence. This multi-center study (ChC\&UES) explores radical radio(chemo)therapy efficacy and safety
Detailed description
Cervical and upper thoracic esophageal cancer (ESCA) are relatively rare diseases, presenting treatment challenges due to limited clinical evidence. This multi-center study (ChC\&UES) explores radical radiotherapy efficacy and safety, especially focusing on radiation dose. This study collected all eligible patients diagnosed with cervical and upper thoracic ESCA from 6 medical centers (Tianjin Cancer Hospital, Cancer Hospital of the Chinese Academy of Medical Sciences, Fujian Cancer Hospital, Fudan University Shanghai Cancer Center, Shandong Cancer Hospital and the Fourth Hospital of Hebei Medical University) in China. Patients were categoried into two group (low dose radiation group and high dose radiation group) based on radiation dose. Basic clinical information, including age, gender, ECOG score, pathological type, smoking and drinking history, initial visit date, radiotherapy dose, radiotherapy method, concurrent chemotherapy modality, immunotherapy, targeted drug usage, treatment efficacy assessment, toxicity and side effects and survival time was collected. Kaplan-Meier method was used to calculate OS, survival differences were assessed using the log-rank test. Univariate analysis was conducted via Cox regression modeling, with variables demonstrating P values < 0.1 being included in multivariate analysis. A significance level of two-sided P < 0.05 was considered statistically significant. The aim of this study was to compared the overall survival time between low dose radiation group and high dose radiation dose group and compared the underlying side effects.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose radiotherapy (≥60Gy) | – | –Patients who received 60 Gy or more than 60Gy radiation dose for radical radiation therapy for the primary tumor. |
| Low dose radiotherapy (50-<60Gy) | – | –Patients who received 50-<60Gy radiation dose for radical radiation therapy for the primary tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a real-world study. All esophageal cancer patients over 18 years old who received radical radiotherapy in cervical and upper thoracic segment eligible for inclusion were retrospectively collected. This study is a reflection of real-world, no restriction on treatment was made.
Key inclusion criteria (9 listed)
- Age 18 and older.
- Confirmation of esophageal cancer through histopathology or cytology.
- Primary tumor location within the cervical or upper thoracic segment, extending from the upper esophageal sphincter to the azygos vein.
- Absence of distant metastasis.
- Patients unable or unwilling to undergo surgical treatment for various reasons.
Key exclusion criteria (7 listed)
- Receipt of radiation dose below 50Gy.
- History of other malignancies (except for cured cancer in situ and malignancies cured for over 5 years) or laryngeal invasion.
- Diagnosis of double primary esophageal cancer.
- Prior chest radiation therapy within the past 5 years.
- Recurrent or metastatic esophageal cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival time (OS)
Time frame: 2000.1.1-2024.6.20
Compared the differences in overall survival (OS) between low dose radiation and high dose radiation group after definitive radiotherapy. OS is defined as time from start of enrollment to death from any cause.
progression-free survival (PFS)
Time frame: 2000.1.1-2024.6.20
Progression-free survival (PFS) is defined as the time from the start of enrollment until tumor progression or death from any cause.
1 secondary outcome
Objective response rate (ORR)
Time frame: 2000.1.1-2024.6.20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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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.
Wenbin Shen principal investigator
Hebei Medical University Fourth Hospital
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 Neoplasm, run by Hebei Medical University Fourth Hospital 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 9 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Shen (+86 15831183879, wbshen2024@hebmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival time (OS) (time frame: 2000.1.1-2024.6.20). The study lists 2 primary outcomes in all. 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 1 Jul 2024.