Esophagus CancerESCORTNCT06385717
Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer
An observational study of Esophagus Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites in China.
Trial summary
This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophagus Cancer
- What is being tested?
- chemo-radiation
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2024to 31 Jan 2029
- How long will I take part?
- 3 Years
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Esophageal cancer patients, and pathologic-comfirmed pT1a-MM stage or pT1b stage
Who may be able to join
- 1. Esophageal cancer patients who are pathologically confirmed as pT1a-MM stage or pT1b stage after endoscopic submucosal dissection； 2. No definite contraindications for chemo-radiotherapy； 3. Informed consent has been signed； 4. Refused surgery after endoscopic submucosal dissection.
Who cannot join
- 1. Severe heart, brain, lung disease or renal dysfunction; 2. Previous history of other malignancies; 3. Prior radiation or chemotherapy 4. Researchers consider it inappropriate to participate in this experiment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jing Xu, MD, 0086-0571-87783521, jing_xu@zju.edu.cn
- Not yet recruiting
The Second Affiliated Hospital of Zhejiang University, School of Medicine
Hangzhou
Jing Xu, 0086-0571-87783521, jing_xu@zju.edu.cn
About this study
Official title: Multicenter Cohort Study of Chemo-radiotherapy After Endoscopic Submucosal Dissection for High-risk Early-stage Esophageal Cancer
This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection.
Read the detailed description
Our study can further improve the local-regional lymph nodes control rate and alleviate the toxicity of chemoradiotherapy.
- Conditions
- Esophagus Cancer
- Being tested
- chemo-radiation
- Keywords
- esophagus cancer; radio-chemotherapy; ESD
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemo-radiationRadiation
different Chemo-radiotherapy regimen
| Study group | Role | What they receive |
|---|---|---|
| Prophylactic chemoradiotherapy | pT1a -MM and pT1b-SM1 without pathological risk factors Receives: Radiation: chemo-radiation | |
| Intensive chemoradiotherapy | pT1b-SM2; pT1a -MM and pT1b-SM1 with pathological risk factors Receives: Radiation: chemo-radiation | |
| Radical chemoradiotherapy | Positive vertical margin or unknown margin Receives: Radiation: chemo-radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxic events
esophageal stenosis, radiation pneumonitis, etc
Measured: 2026.2
Secondary outcomes (2)
3-year overall survival
the time from randomization until death from any cause
Measured: 2029.1
3-year local-regional recurrence free survival
the time from randomization until local-regional recurrence
Measured: 2029.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Xu, MD, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385717
- Sponsor's protocol ID
- ZhejiangU
- Acronym
- ESCORT
- Status last verified
- Apr 2024
- First submitted
- 11 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Cohort Study of Chemo-radiotherapy After Endoscopic Submucosal Dissection for High-risk Early-stage Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06385717
- Acronym / sponsor ID
- ESCORT / ZhejiangU
- Conditions
- Esophagus Cancer
- Keywords
- esophagus cancer; radio-chemotherapy; ESD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 26 Apr 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.
This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection.
Detailed description
Our study can further improve the local-regional lymph nodes control rate and alleviate the toxicity of chemoradiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prophylactic chemoradiotherapy | – | Radiation: chemo-radiationpT1a -MM and pT1b-SM1 without pathological risk factors |
| Intensive chemoradiotherapy | – | Radiation: chemo-radiationpT1b-SM2; pT1a -MM and pT1b-SM1 with pathological risk factors |
| Radical chemoradiotherapy | – | Radiation: chemo-radiationPositive vertical margin or unknown margin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Esophageal cancer patients, and pathologic-comfirmed pT1a-MM stage or pT1b stage
Key inclusion criteria (1 listed)
- 1. Esophageal cancer patients who are pathologically confirmed as pT1a-MM stage or pT1b stage after endoscopic submucosal dissection； 2. No definite contraindications for chemo-radiotherapy； 3. Informed consent has been signed； 4. Refused surgery after endoscopic submucosal dissection.
Key exclusion criteria (1 listed)
- 1. Severe heart, brain, lung disease or renal dysfunction; 2. Previous history of other malignancies; 3. Prior radiation or chemotherapy 4. Researchers consider it inappropriate to participate in this experiment
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 |
|---|---|---|
| chemo-radiationdifferent Chemo-radiotherapy regimen | Radiation | Intensive chemoradiotherapy, Prophylactic chemoradiotherapy, Radical chemoradiotherapy |
Primary outcome
Incidence of toxic events
Time frame: 2026.2
esophageal stenosis, radiation pneumonitis, etc
2 secondary outcomes
3-year overall survival
Time frame: 2029.1
3-year local-regional recurrence free survival
Time frame: 2029.1
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 26 Apr 2024.
- 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.
Jing Xu, MD study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 2 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Jing Xu, MD (0086-0571-87783521, jing_xu@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of toxic events (time frame: 2026.2). 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 26 Apr 2024.