Esophageal Squamous Cell CarcinomaNCT07879898
Radiotherapy Target Volume in Locally Advanced Esophageal Squamous Cell Carcinoma in the Immunotherapy Era
An observational study of Esophageal Squamous Cell Carcinoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This retrospective real-world cohort study will evaluate the efficacy and safety of different radiotherapy target volume extents in patients with locally advanced esophageal squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 23 Jan 2018to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with locally advanced esophageal squamous cell carcinoma who received definitive or preoperative radiotherapy at the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, between January 1, 2018 and July 15, 2026 will be retrospectively identified from existing clinical records. Eligible patients will be consecutively screened according to predefined inclusion and exclusion criteria. Data will be obtained from electronic medical records, imaging systems, pathology databases, radiotherapy planning systems, DICOM-RT files, treatment records, surgical records, and routine follow-up data. Treatment decisions were made in routine clinical practice and were not assigned or modified by this study.
Who may be able to join
- Age ≥18 years at the start of treatment, regardless of sex.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma.
- Clinical stage cT2-4aN0-3M0 and received definitive radiotherapy or preoperative radiotherapy, with systemic treatment consisting of concurrent chemoradiotherapy with or without immunotherapy.
- Received modern precision radiotherapy, including IMRT, VMAT, TOMO, or proton therapy, with the original radiotherapy plan, target structures, and dose distribution available for review.
- Contrast-enhanced CT available before treatment for staging and target volume review; endoscopy, EUS, PET/CT, or MRI may also be used when available.
- Major baseline characteristics, treatment information, and at least one efficacy or safety assessment available in the medical record; this requirement does not apply to patients who died during treatment.
- Treatment occurred within the predefined study period and met the data-use conditions approved by the ethics committee.
Who cannot join
- Distant metastasis, malignant pleural or peritoneal effusion before treatment, or radiotherapy given with a clearly palliative intent.
- Previous thoracic radiotherapy that could substantially affect current target volume design, dosimetric assessment, or outcome evaluation.
- Other active malignancies that could substantially affect survival or recurrence outcomes.
- Missing original radiotherapy plan or DICOM-RT data, preventing determination of the GTV-CTV longitudinal margin, regional lymph node irradiation extent, or key dosimetric parameters.
- Severe missing clinical, pathological, or follow-up data preventing determination of the primary exposure or major outcomes.
- Duplicate cases; only the first eligible treatment record will be included.
Trial locations and contacts
1 site in 1 country.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
About this study
Official title: Efficacy and Safety of Different Radiotherapy Target Volume Extents in Locally Advanced Esophageal Squamous Cell Carcinoma in the Immunotherapy Era: A Real-World Cohort Study
This retrospective real-world cohort study will evaluate the efficacy and safety of different radiotherapy target volume extents in patients with locally advanced esophageal squamous cell carcinoma.
Patients who previously received definitive or preoperative radiotherapy, with systemic treatment consisting of concurrent chemoradiotherapy with or without immunotherapy, will be identified from existing medical records. The study will not assign or modify any treatment.
Read more
Patients will be classified according to the radiotherapy target volume actually used in clinical practice, including the longitudinal gross tumor volume-to-clinical target volume (GTV-CTV) margin and the extent of regional lymph node irradiation. The study will compare locoregional recurrence-free survival, recurrence patterns, overall survival, progression-free or disease-free survival, treatment completion, treatment-related toxicity, lymphocyte reduction, and postoperative outcomes among different target volume strategies.
The aim is to provide real-world evidence to support individualized radiotherapy target volume selection in locally advanced esophageal squamous cell carcinoma.
Read the detailed description
This is a single-center, non-interventional, retrospective real-world cohort study of patients with locally advanced esophageal squamous cell carcinoma. Eligible patients treated between January 1, 2018 and July 15, 2026 will be identified from existing clinical records. Data will be obtained from electronic medical records, hospital information systems, laboratory systems, imaging systems, pathology databases, radiotherapy treatment planning systems, DICOM-RT files, medication records, surgical records, and routine follow-up data.
The study will include patients who previously received definitive or preoperative radiotherapy using modern radiotherapy techniques. Systemic treatment may include concurrent chemoradiotherapy with or without immunotherapy. All treatment decisions were made by the treating clinical team according to the patient's condition and routine clinical practice. The study does not assign, modify, or influence treatment.
Radiotherapy plans will be retrospectively reviewed. Patients will be classified according to two main exposure dimensions: the longitudinal GTV-CTV margin and the extent of regional lymph node irradiation. For the primary analysis of the longitudinal margin, patients with margins of 2 cm or less on both sides will be classified as the reduced-margin group, whereas patients with a margin greater than 2 cm on either side will be classified as the conventional-margin group. Regional lymph node irradiation will be categorized as involved-field irradiation or partial/elective nodal irradiation according to the original treatment plan.
The primary efficacy outcome is 2-year locoregional recurrence-free survival. Primary safety outcomes include grade 3 or higher treatment-related adverse events occurring from treatment initiation through 90 days after completion of radiotherapy and grade 4 lymphocyte reduction during treatment. Secondary outcomes include overall survival, progression-free survival, disease-free survival in surgical patients, distant metastasis-free survival, recurrence patterns, treatment completion, postoperative outcomes, radiotherapy-related toxicities, and changes in peripheral blood lymphocyte counts.
Propensity score methods, multivariable regression, subgroup analyses, and sensitivity analyses will be used to reduce confounding and evaluate the association between radiotherapy target volume extent and clinical outcomes.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Locally Advanced Esophageal Cancer, Radiotherapy, Immunotherapy, Clinical Target Volume, Target Volume Delineation, GTV-CTV Margin, Involved-Field Irradiation, Elective Nodal Irradiation, Retrospective Cohort Study, Real-World Study
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
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 |
|---|---|---|
| Reduced GTV-CTV Margin Group | Patients whose longitudinal GTV-to-CTV margins are ≤2 cm on both the superior and inferior sides in the original radiotherapy plan. | |
| Conventional GTV-CTV Margin Group | Patients whose longitudinal GTV-to-CTV margin is >2 cm on either the superior or inferior side in the original radiotherapy plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Locoregional Recurrence-Free Survival
Locoregional recurrence-free survival (LRFS) is defined as the time from the start of radiotherapy to recurrence of the primary tumor or regional lymph nodes, death from any cause, or the last follow-up. Locoregional recurrence will be determined based on pathological findings, serial imaging progression, and clinical information.
Measured: Up to 2 years from the start of radiotherapy
Secondary outcomes (1)
2-Year Overall Survival
Overall survival (OS) is defined as the time from initiation of radiotherapy to death from any cause. Patients alive at their last available follow-up will be censored at that date. The 2-year OS probability will be estimated.
Measured: From initiation of radiotherapy to death from any cause or last follow-up, up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start23 Jan 2018
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879898
- Sponsor's protocol ID
- NCC6528
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Different Radiotherapy Target Volume Extents in Locally Advanced Esophageal Squamous Cell Carcinoma in the Immunotherapy Era: A Real-World Cohort Study
- ClinicalTrials.gov ID
- NCT07879898
- Acronym / sponsor ID
- NCC6528
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Locally Advanced Esophageal Cancer, Radiotherapy, Immunotherapy, Clinical Target Volume, Target Volume Delineation, GTV-CTV Margin, Involved-Field Irradiation, Elective Nodal Irradiation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 19 Oct 2026 (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.
This retrospective real-world cohort study will evaluate the efficacy and safety of different radiotherapy target volume extents in patients with locally advanced esophageal squamous cell carcinoma.
Patients who previously received definitive or preoperative radiotherapy, with systemic treatment consisting of concurrent chemoradiotherapy with or without immunotherapy, will be identified from existing medical records. The study will not assign or modify any treatment.
Patients will be classified according to the radiotherapy target volume actually used in clinical practice, including the longitudinal gross tumor volume-to-clinical target volume (GTV-CTV) margin and the extent of regional lymph node irradiation. The study will compare locoregional recurrence-free survival, recurrence patterns, overall survival, progression-free or disease-free survival, treatment completion, treatment-related toxicity, lymphocyte reduction, and postoperative outcomes among different target volume strategies.
The aim is to provide real-world evidence to support individualized radiotherapy target volume selection in locally advanced esophageal squamous cell carcinoma.
Detailed description
This is a single-center, non-interventional, retrospective real-world cohort study of patients with locally advanced esophageal squamous cell carcinoma. Eligible patients treated between January 1, 2018 and July 15, 2026 will be identified from existing clinical records. Data will be obtained from electronic medical records, hospital information systems, laboratory systems, imaging systems, pathology databases, radiotherapy treatment planning systems, DICOM-RT files, medication records, surgical records, and routine follow-up data.
The study will include patients who previously received definitive or preoperative radiotherapy using modern radiotherapy techniques. Systemic treatment may include concurrent chemoradiotherapy with or without immunotherapy. All treatment decisions were made by the treating clinical team according to the patient's condition and routine clinical practice. The study does not assign, modify, or influence treatment.
Radiotherapy plans will be retrospectively reviewed. Patients will be classified according to two main exposure dimensions: the longitudinal GTV-CTV margin and the extent of regional lymph node irradiation. For the primary analysis of the longitudinal margin, patients with margins of 2 cm or less on both sides will be classified as the reduced-margin group, whereas patients with a margin greater than 2 cm on either side will be classified as the conventional-margin group. Regional lymph node irradiation will be categorized as involved-field irradiation or partial/elective nodal irradiation according to the original treatment plan.
The primary efficacy outcome is 2-year locoregional recurrence-free survival. Primary safety outcomes include grade 3 or higher treatment-related adverse events occurring from treatment initiation through 90 days after completion of radiotherapy and grade 4 lymphocyte reduction during treatment. Secondary outcomes include overall survival, progression-free survival, disease-free survival in surgical patients, distant metastasis-free survival, recurrence patterns, treatment completion, postoperative outcomes, radiotherapy-related toxicities, and changes in peripheral blood lymphocyte counts.
Propensity score methods, multivariable regression, subgroup analyses, and sensitivity analyses will be used to reduce confounding and evaluate the association between radiotherapy target volume extent and clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced GTV-CTV Margin Group | – | –Patients whose longitudinal GTV-to-CTV margins are ≤2 cm on both the superior and inferior sides in the original radiotherapy plan. |
| Conventional GTV-CTV Margin Group | – | –Patients whose longitudinal GTV-to-CTV margin is >2 cm on either the superior or inferior side in the original radiotherapy plan. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced esophageal squamous cell carcinoma who received definitive or preoperative radiotherapy at the Cancer Institute and Hospital, Chinese Academy of Medical Sciences, between January 1, 2018 and July 15, 2026 will be retrospectively identified from existing clinical records. Eligible patients will be consecutively screened according to predefined inclusion and exclusion criteria. Data will be obtained from electronic medical records, imaging systems, pathology databases, radiotherapy planning systems, DICOM-RT files, treatment records, surgical records, and routine follow-up data. Treatment decisions were made in routine clinical practice and were not assigned or modified by this study.
Key inclusion criteria (7 listed)
- Age ≥18 years at the start of treatment, regardless of sex.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma.
- Clinical stage cT2-4aN0-3M0 and received definitive radiotherapy or preoperative radiotherapy, with systemic treatment consisting of concurrent chemoradiotherapy with or without immunotherapy.
- Received modern precision radiotherapy, including IMRT, VMAT, TOMO, or proton therapy, with the original radiotherapy plan, target structures, and dose distribution available for review.
- Contrast-enhanced CT available before treatment for staging and target volume review; endoscopy, EUS, PET/CT, or MRI may also be used when available.
Key exclusion criteria (6 listed)
- Distant metastasis, malignant pleural or peritoneal effusion before treatment, or radiotherapy given with a clearly palliative intent.
- Previous thoracic radiotherapy that could substantially affect current target volume design, dosimetric assessment, or outcome evaluation.
- Other active malignancies that could substantially affect survival or recurrence outcomes.
- Missing original radiotherapy plan or DICOM-RT data, preventing determination of the GTV-CTV longitudinal margin, regional lymph node irradiation extent, or key dosimetric parameters.
- Severe missing clinical, pathological, or follow-up data preventing determination of the primary exposure or major outcomes.
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
2-Year Locoregional Recurrence-Free Survival
Time frame: Up to 2 years from the start of radiotherapy
Locoregional recurrence-free survival (LRFS) is defined as the time from the start of radiotherapy to recurrence of the primary tumor or regional lymph nodes, death from any cause, or the last follow-up. Locoregional recurrence will be determined based on pathological findings, serial imaging progression, and clinical information.
1 secondary outcome
2-Year Overall Survival
Time frame: From initiation of radiotherapy to death from any cause or last follow-up, up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Squamous Cell Carcinoma, run by Cancer Institute and Hospital, 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
2-Year Locoregional Recurrence-Free Survival (time frame: Up to 2 years from the start of radiotherapy). 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 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.