Esophageal CancerPhase 3NCT04135664
Comparison of Esophagectomy and Chemoradiation for Patients With cN0-pT1b Stage Esophageal Squamous Cell Carcinoma
A Phase 3 study testing esophagectomy, chemoradiation and active surveillance in people with Esophageal Cancer, run by Shanghai Chest Hospital at 6 sites in China.
Trial summary
The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- esophagectomy, chemoradiation and active surveillance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 6 sitesChina
- Study dates
- 1 Sep 2019to 1 Dec 2027
- Phase
- Phase 3
- 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
Who may be able to join
- Biopsy proven with esophageal squamous cell cancer.
- Clinical N0 stage diagnosed by imaging examinations.
- Pathological T1b stage confirmed by endoscopic submucosal dissection.
- Age: 18-75.
- Tumor located at the thorax.
- Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Written informed consent.
Who cannot join
- Prior intervention treatment before endoscopic submucosal resection.
- Inability to accept any treatment component.
- Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease.
- Distant metastasis.
- The circumference of the lumen over 3/4
- Main tumor size > 5cm assessed by endoscopy
- Inability to understand the informed consent.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 1 recruiting
- Active, not recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, JX 791
- Active, not recruiting
Changhai Hospital, The Second Military Medical University
Shanghai, SH 21
- Active, not recruiting
Ruijin Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, SH 21
- Recruiting
Shanghai Chest Hospital, Shanghai Jiao Tong University
Shanghai, SH 21
Zhigang Li, Doctor, 86-18930619260 ext. 18960619260, dr_lizhigang@163.com
- Active, not recruiting
Zhongshan Hospital, Fudan University
Shanghai, SH 21
- Active, not recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin
About this study
Official title: Adjuvant Esophagectomy Versus Chemoradiation for Patients With Clinical Stage N0 and Pathological Stage T1b (After Endoscopic Submucosal Dissection, ESD) Esophageal Squamous Cell Carcinoma (Ad-ESD Trial): a Multicentric, Open Label, Randomized Trial
The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).
Read the detailed description
Esophagectomy is still the primary treatment for pathological T1b esophageal squamous cell carcinoma. However, esophagectomy is associated with high mortality and morbidity and decreased quality of life. Endoscopic resection followed with chemoradiation had showed uncompromised oncological outcomes with esophagectomy. But there is no well-designed, phase III trial to compare the two treatment for patients with pT1b squamous cell carcinoma.
The ad-ESD trial is a multi-center prospective superiority trial, combied of a randomized clinical trial and a prospective registry.
The experimental design produces two randomized arms; (1) esophagectomy and (2) chemoradiation. An additional registry arm will be based on surgeons/patients that do not want to be randomised because of their own experience on adjuvant therapy, including esophagectomy; chemoradiation and active surveillance.
The primary endpoint is to evaluate the difference of 5-year overall survival rate between definitive chemoradiation and esophagectomy, in patients with cN0-pT1b esophageal squamous cell cancer (ESCC) after endoscopic resection.
The secondary endpoints are to evaluate the difference of quality of life and oncological outcomes including 3-year overall survival (OS) and 3, 5-year relapse free survival (RFS) between the two treatments.
- Conditions
- Esophageal Cancer
- Being tested
- esophagectomy, chemoradiation, active surveillance
- Keywords
- esophagectomy, chemoradiation, esophageal cancer, endoscopic submucosal dissection
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagectomyProcedure or surgery
esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
chemoradiationCombination product
concurrent chemotherapy and radiotherapy
active surveillanceOther
No further adjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing adjuvant esophagectomy | Active comparator | Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma.
Patients randomized into undergoing adjvant esophagectomy. Receives: Procedure: esophagectomy |
| Patients undergoing adjuvant chemoradiation | Experimental | Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma.
Patients randomized into undergoing adjvant chemoradiation. Receives: Combination Product: chemoradiation |
| Prospective registry of patients that cannot be randomized | Active comparator | Patients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma.
Patients cannot be randomized into undergoing adjvant esophagectomy or chemoradiaton.
This arm includes patients undergoing adjuvant esophagectomy; adjuvant chemoradiation and active surveillance. Receives: Procedure: esophagectomy; Combination Product: chemoradiation; Other: active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year overall survival rate
The overall survival is defined as days from date of randomization to death from any cause, and cencored at the last day of follow up when patients are alive.
Measured: 5 years after enrollment day
Secondary outcomes (5)
3-year overall survival rate
The overall survival is defined as days from date of randomization to death from any cause, and cencored at the last day of follow up when patients are alive.
Measured: 3 years after enrollment day
3-year relapse free survival rate
The relapse free survival is defined as days from date of randomization until the date of tumor progression or the date of death causing of any reasons, and cencored at the last day of follow up when patients are alive.
Measured: 3 years after enrollment day
5-year relapse free survival rate
The relapse free survival is defined as days from date of randomization until the date of tumor progression or the date of death causing of any reasons, and cencored at the last day of follow up when patients are alive.
Measured: 5 years after enrollment day
Quality of life differences (EORTC QLQ-C30)
The quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-C30) questionnaire. Patients will be invited to finish the questionnaire at the day of recruitment, 1st, 3rd, 6th, 12th and 24th month after randomization.
Measured: 1st, 3rd, 6th, 12th and 24th month after enrollment
Quality of life differences (EORTC QLQ-OES18)
The quality of life will be assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ-OES18) questionnaire. Patients will be invited to finish the questionnaire at the day of recruitment, 1st, 3rd, 6th, 12th and 24th month after randomization.
Measured: 1st, 3rd, 6th, 12th and 24th month after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Sep 2019
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Li, Shanghai Chest Hospital
- Investigators
- Zhigang Li, MD, PhD, Principal investigator, Shanghai Chest Hospital of Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135664
- Sponsor's protocol ID
- Chest201908
- Status last verified
- Aug 2019
- First submitted
- 9 Oct 2019
- Last updated
- 22 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang Y, Su Y, Zhang X, Liu J, Zhang H, Li B, Hua R, Tan L, Chen H, Li Z. Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial). Trials. 2020 Jul 1;21(1):603. doi: 10.1186/s13063-020-04461-5.
PubMed 32611448
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Esophagectomy Versus Chemoradiation for Patients With Clinical Stage N0 and Pathological Stage T1b (After Endoscopic Submucosal Dissection, ESD) Esophageal Squamous Cell Carcinoma (Ad-ESD Trial): a Multicentric, Open Label, Randomized Trial
- ClinicalTrials.gov ID
- NCT04135664
- Acronym / sponsor ID
- Chest201908
- Conditions
- Esophageal Cancer
- Keywords
- esophagectomy, chemoradiation, esophageal cancer, endoscopic submucosal dissection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 22 Oct 2019 (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.
The ad-ESD trial is phase III randomized trial to compare adjuvant esophagectomy and chemoradiation for patients with clinical stage N0 and pathological stage T1b squamous cell carcinoma (after endoscopic submucosal dissection).
Detailed description
Esophagectomy is still the primary treatment for pathological T1b esophageal squamous cell carcinoma. However, esophagectomy is associated with high mortality and morbidity and decreased quality of life. Endoscopic resection followed with chemoradiation had showed uncompromised oncological outcomes with esophagectomy. But there is no well-designed, phase III trial to compare the two treatment for patients with pT1b squamous cell carcinoma.
The ad-ESD trial is a multi-center prospective superiority trial, combied of a randomized clinical trial and a prospective registry.
The experimental design produces two randomized arms; (1) esophagectomy and (2) chemoradiation. An additional registry arm will be based on surgeons/patients that do not want to be randomised because of their own experience on adjuvant therapy, including esophagectomy; chemoradiation and active surveillance.
The primary endpoint is to evaluate the difference of 5-year overall survival rate between definitive chemoradiation and esophagectomy, in patients with cN0-pT1b esophageal squamous cell cancer (ESCC) after endoscopic resection.
The secondary endpoints are to evaluate the difference of quality of life and oncological outcomes including 3-year overall survival (OS) and 3, 5-year relapse free survival (RFS) between the two treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing adjuvant esophagectomy | Active comparator | Procedure: esophagectomyPatients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma. Patients randomized into undergoing adjvant esophagectomy. |
| Patients undergoing adjuvant chemoradiation | Experimental | Combination Product: chemoradiationPatients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma. Patients randomized into undergoing adjvant chemoradiation. |
| Prospective registry of patients that cannot be randomized | Active comparator | Procedure: esophagectomy, Combination Product: chemoradiation, Other: active surveillancePatients underwent endoscopic submucosal dissection and diagnosed with pathological-T1b and clinical-N0 squamous cell carcinoma. Patients cannot be randomized into undergoing adjvant esophagectomy or chemoradiaton. This arm includes patients undergoing adjuvant esophagectomy; adjuvant chemoradiation and active surveillance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Biopsy proven with esophageal squamous cell cancer.
- Clinical N0 stage diagnosed by imaging examinations.
- Pathological T1b stage confirmed by endoscopic submucosal dissection.
- Age: 18-75.
- Tumor located at the thorax.
Key exclusion criteria (7 listed)
- Prior intervention treatment before endoscopic submucosal resection.
- Inability to accept any treatment component.
- Prior intervention (surgery, chemoradiation, et al.) for other primary tumor disease.
- Distant metastasis.
- The circumference of the lumen over 3/4
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 |
|---|---|---|
| esophagectomyesophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy | Procedure or surgery | Patients undergoing adjuvant esophagectomy, Prospective registry of patients that cannot be randomized |
| chemoradiationconcurrent chemotherapy and radiotherapy | Combination product | Patients undergoing adjuvant chemoradiation, Prospective registry of patients that cannot be randomized |
| active surveillanceNo further adjuvant therapy | Other | Prospective registry of patients that cannot be randomized |
Primary outcome
5-year overall survival rate
Time frame: 5 years after enrollment day
The overall survival is defined as days from date of randomization to death from any cause, and cencored at the last day of follow up when patients are alive.
5 secondary outcomes
3-year overall survival rate
Time frame: 3 years after enrollment day
3-year relapse free survival rate
Time frame: 3 years after enrollment day
5-year relapse free survival rate
Time frame: 5 years after enrollment day
Quality of life differences (EORTC QLQ-C30)
Time frame: 1st, 3rd, 6th, 12th and 24th month after enrollment
Quality of life differences (EORTC QLQ-OES18)
Time frame: 1st, 3rd, 6th, 12th and 24th month after enrollment
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 22 Oct 2019.
- Derived from this study: PubMed 32611448Yang Y, Su Y, Zhang X, Liu J, Zhang H, Li B, Hua R, Tan L, Chen H, Li Z. Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial). Trials. 2020 Jul 1;21(1):603. doi: 10.1186/s13063-020-04461-5.
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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.
Zhigang Li, MD, PhD principal investigator
Shanghai Chest Hospital of Shanghai Jiao Tong University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing esophagectomy, chemoradiation and active surveillance in people with Esophageal Cancer, run by Shanghai Chest Hospital at 6 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 7 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: looking for participants now, as of the sponsor's last update on 22 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhigang Li, MD (18960619260 ext. 18960619260, dr_lizhigang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year overall survival rate (time frame: 5 years after enrollment day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04135664, which also lists 1 linked publication.
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 22 Oct 2019.