Esophageal Squamous Cell CarcinomaPhase 2NCT04275986
Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Carcinoma
A Phase 2 study testing Intensity modulated radiotherapy (IMRT) and Chemotherapy in people with Esophageal Squamous Cell Carcinoma, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a prospective single-arm study of endoscopic resection (ER) following concurrent chemoradiotherapy for stage I esophageal squamous cell carcinoma, to find if the treatment combination is useful by assessing its safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Intensity modulated radiotherapy (IMRT) and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2020to Mar 2024
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18 to 75 years (18 years and 75 years are inclusive).
- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 1 point.
- Weight loss (intentional or unintentional) of less than or equal to 10% of body weight in the 6 months prior to surgery.
- Complete radiological staging is required before ER, including gastroscopy, endoscopic ultrasonography, chest CT, brain MRI and bone scan (if positive, bone metastasis must be confirmed by MRI or CT examination of corresponding parts, otherwise bone metastasis cannot be determined). No lymph nodes with shorter diameter >10mm in mediastinum presented by endoscopic ultrasonography or chest CT. No abdominal nor neck lymph node metastases presented by B-ultrasound.
- Primary lesion located in thoracic esophagus.
- Clinical stage: cT1（sm1/sm2）N0M0 (The 8th edition of American Joint Committee on Cancer [AJCC]) before ER.
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- ER is a complete removal of tumor.
- Pathologically confirmed squamous cell carcinoma.
- Histologically confirmed diagnosis of T1a with LVI, T1b（sm1/sm2）with/without LVI, or microscopically positive vertical resection margin (R1 resection).
- Less than three endoscopically resected synchronous lesions with high risk factors (lymphovascular or mucous membrane invasion, submucous infiltration, poor differentiation or microscopically positive vertical resection margin), which can be safely encompassed in a tolerable radiation plan.
- Non-pregnancy and non-pregnancy plan in the next 12 months (urine pregnancy test or blood pregnancy test is required for women of childbearing age to exclude pregnancy).
- No serious medical disease nor organ dysfunction. Adequate BM, liver, kidney and heart function.
- Meet the treatment and follow-up criteria, able to receive treatment, follow-up and pathological examination. The subject has voluntarily signed the written informed consent form (ICF).
Who cannot join
- Any positive N or M stage.
- Macroscopic residual tumor (R2 resection).
- Lesions with poor prognistic factors (lymphovascular or mucous membrane invasion, submucous infiltration, poor differentiation or microscopically positive vertical resection margin) solely resected endoscopically more than six months before evaluation.
- Patients with other malignant tumors within 5 years before enrollment.
- Unavailable gastroscope due to esophageal stenosis.
- Previously received electrocoagulation, other treatments (including photodynamic therapy, multipolar electrocoagulation, argon plasma coagulation, laser therapy, et al.) or radiotherapy.
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- Previously received any esophageal surgery, excluding fundoplication with no complications (no slippage, dysphagia, et al.).
- Uncontrolled coagulation disorders: INR >2 or PLT<75,000/μL.
- Patients who are taking or have taken (within 7 days before/after treatment) aspirin, clopidogrel or other non-steroidal anti-inflammatory drugs.
- Patients with history of uncontrolled drug or alcohol dependence that limits the ability to understand or comply with medical orders, including inability to understand and execute ICF, post-treatment orders, or follow-up guidelines.
- Patients implanted pacemakers, including AICD, nerve stimulator or cardiac pacemaker, without the permission from specialist in charge.
- Patients with mental disease, serious medical disease or major organ dysfunction.
- Pregnant, lactating women or women without offspring.
- Patients unable to understand/express informed or consent.
- Patients with known allergy to platinum compounds or paclitaxel.
- Other circumstances which are considered by the investigator that the subject is unsuitable to be enrolled
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100021
Zhouguang Hui, M.D., 8610-87787230, drhuizg@163.com
Zhouguang Hui, M.D.
About this study
Official title: A Phase II Clinical Trial of Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Squamous Cell Carcinoma
This is a prospective single-arm study of endoscopic resection (ER) following concurrent chemoradiotherapy for stage I esophageal squamous cell carcinoma, to find if the treatment combination is useful by assessing its safety and efficacy.
Read the detailed description
The objectives are to evaluate the efficacy and safety of concurrent chemoradiotherapy after endoscopic resection in early stage esophageal squamous cell carcinoma by evaluating the effectiveness, including 3-year OS, DFS, LRFS, DMFS, LCR, DMR and QOF, and analyzing the toxicity and side effects in 3 years follow-up time.
The study preliminarily explored the recurrence patterns of solely ER for early esophageal squamous cell carcinoma with high risk factors, analyzed the rationality of target areas and dose choices in the treatment regimen of concurrent chemoradiotherapy after ER, and proposed modification schemes of the target area and dose of radiotherapy. Prospectively acquired hematological samples and tissue samples during the treatment will be tested for genetic testing, single-cell genome sequencing, transcriptome and epigenomic analysis, to screen the population with high risk of recurrence or the population who will benefit from this treatment combination.
In terms of sample size, The estimates of survival rate at 3 years for operation group is 85.1% (95% CI: 82.0%, 87.7%) based on SEER study. Assuming that the survival rate at 3 years for ER+CRT is about 90.7%. The difference between operation and ER+CRT is marginal and clinically meaningless. In our study, we will target to establish that the ER+CRT is non-inferiority to operation in term of survival rate at 3 years, and further investigate the benefit of ER+CRT in safety profile and quality of life. A non-inferiority margin 10% is applied with respect to 85.1%. A number of 50 subjects is adequate to achieve 80% statistical power under a type one error rate 0.025 one-sided. The power analysis is based on simulation, 10000 iterations are carried out, Greenwood's method is applied.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Intensity modulated radiotherapy (IMRT), Chemotherapy
- Keywords
- Esophageal Squamous Cell Carcinoma, Endoscopic resection, Concurrent chemoradiotherapy
- 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.
Intensity modulated radiotherapy (IMRT)Procedure or surgery
Intensity-modulated radiation therapy (IMRT) with a total dose of 45Gy in 25 fractions
ChemotherapyDrug
Nedaplatin 25 mg/m2 and Paclitaxel liposome 45mg/m2, day 1, every week, 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Endoscopic resection+ concurrent chemoradiotherapy Receives: Procedure: Intensity modulated radiotherapy (IMRT); Drug: Chemotherapy |
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 time from endoscopic resection to the last follow-up time or death due to any cause.
Measured: 3-year
Adverse events (AE)
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
Measured: 3-year
Secondary outcomes (6)
Disease Free Survival (DFS)
DFS was defined as the time from the date of endoscopic resection to the date of tumor recurrence as assessed by RECIST 1.1, the last follow-up or death.
Measured: 3-year
Local Recurrence Free Survival (LRFS)
LRFS was defined as the time from the date of endoscopic resection to the date of local recurrence (Local recurrence: documented evidence of newly found lesions at the primary surgical site and 1 cm around) as assessed by RECIST 1.1, the last follow-up or death.
Measured: 3-year
Disease Metastasis Free Survival (DMFS)
DMFS was defined as the time from the date of endoscopic resection to the date of tumor metastasis as assessed by RECIST 1.1, the last follow-up or death.
Measured: 3-year
Local Control Rate (LCR)
LCR was defined as percentage of participants who did not have local recurrence as assessed by RECIST 1.1 from the date of endoscopic resection to the date of the last follow-up or death.
Measured: 3-year
Distant Metastasis Rate (DMR)
DMR was defined as percentage of participants who had tumor distant metastasis as assessed by RECIST 1.1 from the date of endoscopic resection to the date of the last follow-up or death.
Measured: 3-year
Quality of Life (QOL): questionnaires
Evaluate the quality of life via questionnaires
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 posted19 Feb 2020
- Study start20 Jan 2020
- Primary completionJan 2024 (estimated)
- Study completionMar 2024 (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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Enrolled Patients will receive concurrent chemoradiotherapy per protocol. The radiotherapy clinical target volume will include 2 cm above and below the tumor bed and high-risk lymph nodal area. Intensity modulated radiotherapy techniques will be used with a total dose of 45Gy in 25 fractions. Chemotherapy will be conducted weekly up to 5 weeks. The specific chemotherapy regimen are Paclitaxel Liposome 45mg/m2, d1 and Nedaplatin 25mg/m2, d1.
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
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
- NCT04275986
- Sponsor's protocol ID
- 19/313-2097
- Status last verified
- Jul 2021
- First submitted
- 17 Feb 2020
- Last updated
- 7 Jul 2021
- 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 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial of Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04275986
- Acronym / sponsor ID
- 19/313-2097
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Esophageal Squamous Cell Carcinoma, Endoscopic resection, Concurrent chemoradiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 19 Feb 2020 (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 is a prospective single-arm study of endoscopic resection (ER) following concurrent chemoradiotherapy for stage I esophageal squamous cell carcinoma, to find if the treatment combination is useful by assessing its safety and efficacy.
Detailed description
The objectives are to evaluate the efficacy and safety of concurrent chemoradiotherapy after endoscopic resection in early stage esophageal squamous cell carcinoma by evaluating the effectiveness, including 3-year OS, DFS, LRFS, DMFS, LCR, DMR and QOF, and analyzing the toxicity and side effects in 3 years follow-up time.
The study preliminarily explored the recurrence patterns of solely ER for early esophageal squamous cell carcinoma with high risk factors, analyzed the rationality of target areas and dose choices in the treatment regimen of concurrent chemoradiotherapy after ER, and proposed modification schemes of the target area and dose of radiotherapy. Prospectively acquired hematological samples and tissue samples during the treatment will be tested for genetic testing, single-cell genome sequencing, transcriptome and epigenomic analysis, to screen the population with high risk of recurrence or the population who will benefit from this treatment combination.
In terms of sample size, The estimates of survival rate at 3 years for operation group is 85.1% (95% CI: 82.0%, 87.7%) based on SEER study. Assuming that the survival rate at 3 years for ER+CRT is about 90.7%. The difference between operation and ER+CRT is marginal and clinically meaningless. In our study, we will target to establish that the ER+CRT is non-inferiority to operation in term of survival rate at 3 years, and further investigate the benefit of ER+CRT in safety profile and quality of life. A non-inferiority margin 10% is applied with respect to 85.1%. A number of 50 subjects is adequate to achieve 80% statistical power under a type one error rate 0.025 one-sided. The power analysis is based on simulation, 10000 iterations are carried out, Greenwood's method is applied.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrolled Patients will receive concurrent chemoradiotherapy per protocol. The radiotherapy clinical target volume will include 2 cm above and below the tumor bed and high-risk lymph nodal area. Intensity modulated radiotherapy techniques will be used with a total dose of 45Gy in 25 fractions. Chemotherapy will be conducted weekly up to 5 weeks. The specific chemotherapy regimen are Paclitaxel Liposome 45mg/m2, d1 and Nedaplatin 25mg/m2, d1.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Procedure: Intensity modulated radiotherapy (IMRT), Drug: ChemotherapyEndoscopic resection+ concurrent chemoradiotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female patients aged 18 to 75 years (18 years and 75 years are inclusive).
- The Eastern Cooperative Oncology Group (ECOG) performance status score is 0 to 1 point.
- Weight loss (intentional or unintentional) of less than or equal to 10% of body weight in the 6 months prior to surgery.
- Complete radiological staging is required before ER, including gastroscopy, endoscopic ultrasonography, chest CT, brain MRI and bone scan (if positive, bone metastasis must be confirmed by MRI or CT examination of corresponding parts, otherwise bone metastasis cannot be determined). No lymph nodes with shorter diameter >10mm in mediastinum presented by endoscopic ultrasonography or chest CT. No abdominal nor neck lymph node metastases presented by B-ultrasound.
- Primary lesion located in thoracic esophagus.
Key exclusion criteria (16 listed)
- Any positive N or M stage.
- Macroscopic residual tumor (R2 resection).
- Lesions with poor prognistic factors (lymphovascular or mucous membrane invasion, submucous infiltration, poor differentiation or microscopically positive vertical resection margin) solely resected endoscopically more than six months before evaluation.
- Patients with other malignant tumors within 5 years before enrollment.
- Unavailable gastroscope due to esophageal stenosis.
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 |
|---|---|---|
| Intensity modulated radiotherapy (IMRT)Intensity-modulated radiation therapy (IMRT) with a total dose of 45Gy in 25 fractions | Procedure or surgery | Experimental arm |
| ChemotherapyNedaplatin 25 mg/m2 and Paclitaxel liposome 45mg/m2, day 1, every week, 5 weeks | Drug | Experimental arm |
Primary outcome
Overall survival (OS)
Time frame: 3-year
OS was defined as the time from endoscopic resection to the last follow-up time or death due to any cause.
Adverse events (AE)
Time frame: 3-year
An AE was defined as any untoward medical occurrence in a participant administered study treatment and which did not necessarily have to have a causal relationship with this treatment.
6 secondary outcomes
Disease Free Survival (DFS)
Time frame: 3-year
Local Recurrence Free Survival (LRFS)
Time frame: 3-year
Disease Metastasis Free Survival (DMFS)
Time frame: 3-year
Local Control Rate (LCR)
Time frame: 3-year
Distant Metastasis Rate (DMR)
Time frame: 3-year
Quality of Life (QOL): questionnaires
Time frame: 3-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensity modulated radiotherapy (IMRT) and Chemotherapy in people with Esophageal Squamous Cell Carcinoma, 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 13 inclusion and 16 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 7 Jul 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zhouguang Hui, M.D. (8610-87787230, drhuizg@163.com), or a site near the patient. 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 7 Jul 2021.