Esophageal CancerNCT05499195
Adjuvant Radiotherapy for pT1b Esophageal Cancer After Submucosal Endoscopic Resection
An observational study of Esophageal Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Endoscopic Resection (ER) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. However, lymph node metastasis rate in pT1b patients is relatively high. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Esophageal Cancer
- Type of treatment
- Injection or infusion
- How many people
- 159 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Jun 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who met the inclusion and exclusion Criteria treated in 11 hospitals in China were included.
Who may be able to join
- ECOG score < 2; (2) Pathologically confirmed squamous or adenosquamous cell cancer; (3) Clinical stage cTis-1bN0M0; (4) Multiple primary T1 lesions were allowed; (5) No lymph nodes and distant metastases confirmed by chest CT, neck CT or neck ultrasound, and abdominal CT or abdominal ultrasound; (6) Underwent ESD between January 2010 and December 2019; (7) pT1b disease confirmed by endoscopically resected specimen; (8) Underwent adjuvant radiotherapy (with or without chemotherapy) or surveillance after ESD.
Who cannot join
- Diagnosed with other locally-advanced or advanced malignancies within 3 years before ESD; (2) Underwent radical surgery after ESD; (3) Upfront radiotherapy, chemotherapy or chemoradiotherapy before ESD; (4) Lost to follow-up or insufficient clinical information.
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
About this study
Official title: Selective Adjuvant Radiotherapy for pT1b Esophageal Cancer After Submucosal Endoscopic Resection- a Multicenter, Retrospective Study
Endoscopic Resection (ER) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. However, lymph node metastasis rate in pT1b patients is relatively high. Although, adjuavnt chemoradiotherapy is recommended, limied studies prove the superiority of additional adjuvant radiotherapy over ESD alone. This study aimed to further verify the efficacy of adjuvant radiotherapy in early-stage esophageal cancer after ESD.
Read the detailed description
The incidence of early-stage esophageal cancer (EC) is increasing rapidly and even accounting for approximately 40% of esophageal squamous cell carcinoma. Endoscopic Resection (ER) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. However, lymph node metastasis rate in pT1b patients is relatively high, and additional treatment is recommended after ER.
Adjuvant chemoradiotherapy is a treatment option and has already been proven to be equivalent to radical surgery. However, limited studies, with relatively small sample size and nature of low-level evidence, consistently showed that additional adjuvant radiotherapy failed to improve survival. Hence, adjuvant radiotherapy should not be applied without selection.
T1b EC patients are a heterogeneous population, with reported regional metastasis or recurrence rates varying considerably from 0-53% in SM1 disease, 19-31% in SM2, and 36-61% in SM3. The risk factors of regional metastasis or recurrence were also reported, generally including lymphovascular invasion (LVI) and pT1b disease.
In view of the aforementioned evidence, we hypothesized that selective adjuvant radiotherapy based on risk factors might significantly improve survival. The aim of this study was to evaluate the efficacy of adjuvant radiotherapy after ESD for pT1b EC and further explore the potential population who could benefit.
- Conditions
- Esophageal Cancer
- Keywords
- early-stage, submucosal endoscopic resection, adjuvant radiotherapy
- 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 |
|---|---|---|
| ESD group | ESD was performed by a highly experienced endoscopist who underwent systemic training. First, the endoscopist carried out chromoendoscopy by spraying 1.25% Lugol's iodine solution to identify the lesion and made dots with a dual-knife outside the margin of the lesion. Next, a forward-viewing endoscope was introduced with a transparent cap attachment on its tip. A saline solution with methylene blue and epinephrine was injected into the submucosa with an injection needle to create a liquid cushion separating the lesion and the muscle layer. Then, a mucosal incision at the periphery of the marking dots was performed with a dual-knife. After that, the submucosal connective tissue beneath the lesion was dissected using the same dual-knife, and the lesion was totally removed through dissection. | |
| ESD+adjuvant radiotherapy group | The process of ESD was the same as that of ESD group. A total dose of 41.4-60.0 Gy in common fractionation based on three-dimensional conformal radiotherapy or intensity modulated radiotherapy technology was prescribed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS was defined as the duration between diagnosis and any cause of death.
Measured: 3-year
Disease-free Survival (DFS)
DFS was defined as the duration between the diagnosis and any disease recurrence or any cause of death, whichever occurred first.
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Mar 2021
- Primary completion15 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- Cross-sectional
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhouguang Hui, M.D., Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05499195
- Sponsor's protocol ID
- NCC2690
- Status last verified
- Aug 2022
- First submitted
- 10 Aug 2022
- Last updated
- 12 Aug 2022
- 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 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Adjuvant Radiotherapy for pT1b Esophageal Cancer After Submucosal Endoscopic Resection- a Multicenter, Retrospective Study
- ClinicalTrials.gov ID
- NCT05499195
- Acronym / sponsor ID
- NCC2690
- Conditions
- Esophageal Cancer
- Keywords
- early-stage, submucosal endoscopic resection, adjuvant radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 12 Aug 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.
Endoscopic Resection (ER) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. However, lymph node metastasis rate in pT1b patients is relatively high. Although, adjuavnt chemoradiotherapy is recommended, limied studies prove the superiority of additional adjuvant radiotherapy over ESD alone. This study aimed to further verify the efficacy of adjuvant radiotherapy in early-stage esophageal cancer after ESD.
Detailed description
The incidence of early-stage esophageal cancer (EC) is increasing rapidly and even accounting for approximately 40% of esophageal squamous cell carcinoma. Endoscopic Resection (ER) is a crucial therapeutic and diagnostic method for superficial esophageal cancer. However, lymph node metastasis rate in pT1b patients is relatively high, and additional treatment is recommended after ER.
Adjuvant chemoradiotherapy is a treatment option and has already been proven to be equivalent to radical surgery. However, limited studies, with relatively small sample size and nature of low-level evidence, consistently showed that additional adjuvant radiotherapy failed to improve survival. Hence, adjuvant radiotherapy should not be applied without selection.
T1b EC patients are a heterogeneous population, with reported regional metastasis or recurrence rates varying considerably from 0-53% in SM1 disease, 19-31% in SM2, and 36-61% in SM3. The risk factors of regional metastasis or recurrence were also reported, generally including lymphovascular invasion (LVI) and pT1b disease.
In view of the aforementioned evidence, we hypothesized that selective adjuvant radiotherapy based on risk factors might significantly improve survival. The aim of this study was to evaluate the efficacy of adjuvant radiotherapy after ESD for pT1b EC and further explore the potential population who could benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESD group | – | –ESD was performed by a highly experienced endoscopist who underwent systemic training. First, the endoscopist carried out chromoendoscopy by spraying 1.25% Lugol's iodine solution to identify the lesion and made dots with a dual-knife outside the margin of the lesion. Next, a forward-viewing endoscope was introduced with a transparent cap attachment on its tip. A saline solution with methylene blue and epinephrine was injected into the submucosa with an injection needle to create a liquid cushion separating the lesion and the muscle layer. Then, a mucosal incision at the periphery of the marking dots was performed with a dual-knife. After that, the submucosal connective tissue beneath the lesion was dissected using the same dual-knife, and the lesion was totally removed through dissection. |
| ESD+adjuvant radiotherapy group | – | –The process of ESD was the same as that of ESD group. A total dose of 41.4-60.0 Gy in common fractionation based on three-dimensional conformal radiotherapy or intensity modulated radiotherapy technology was prescribed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who met the inclusion and exclusion Criteria treated in 11 hospitals in China were included.
Key inclusion criteria (1 listed)
- ECOG score < 2; (2) Pathologically confirmed squamous or adenosquamous cell cancer; (3) Clinical stage cTis-1bN0M0; (4) Multiple primary T1 lesions were allowed; (5) No lymph nodes and distant metastases confirmed by chest CT, neck CT or neck ultrasound, and abdominal CT or abdominal ultrasound; (6) Underwent ESD between January 2010 and December 2019; (7) pT1b disease confirmed by endoscopically resected specimen; (8) Underwent adjuvant radiotherapy (with or without chemotherapy) or surveillance after ESD.
Key exclusion criteria (1 listed)
- Diagnosed with other locally-advanced or advanced malignancies within 3 years before ESD; (2) Underwent radical surgery after ESD; (3) Upfront radiotherapy, chemotherapy or chemoradiotherapy before ESD; (4) Lost to follow-up or insufficient clinical information.
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 (OS)
Time frame: 3-year
OS was defined as the duration between diagnosis and any cause of death.
Disease-free Survival (DFS)
Time frame: 3-year
DFS was defined as the duration between the diagnosis and any disease recurrence or any cause of death, whichever occurred first.
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 12 Aug 2022.
- 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 Cancer, 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 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: finished, as of the sponsor's last update on 12 Aug 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 (OS) (time frame: 3-year). 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 12 Aug 2022.