Concurrent Chemoradiotherapy After Endoscopic Resection for Stage I Esophageal Carcinoma

July 5, 2021 updated by: Zhouguang Hui, M.D., Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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).

Exclusion Criteria:

  • 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.
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental arm
Endoscopic resection+ concurrent chemoradiotherapy
Procedure: Intensity modulated radiotherapy (IMRT)
Intensity-modulated radiation therapy (IMRT) with a total dose of 45Gy in 25 fractions
Drug: Chemotherapy
Nedaplatin 25 mg/m2 and Paclitaxel liposome 45mg/m2, day 1, every week, 5 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3-year
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.
3-year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease Free Survival (DFS)
Time Frame: 3-year
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.
3-year
Local Recurrence Free Survival (LRFS)
Time Frame: 3-year
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.
3-year
Disease Metastasis Free Survival (DMFS)
Time Frame: 3-year
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.
3-year
Local Control Rate (LCR)
Time Frame: 3-year
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.
3-year
Distant Metastasis Rate (DMR)
Time Frame: 3-year
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.
3-year
Quality of Life (QOL): questionnaires
Time Frame: 3-year
Evaluate the quality of life via questionnaires
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19/313-2097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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