Esophageal CancerASSURENCT03306901
Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma
A study testing Esophagectomy, 5-fluorouracil and Cisplatin in people with Esophageal Cancer, run by Samsung Medical Center at 9 sites in South Korea.
Trial summary
This is a randomized noninferiority multicenter trial. Patients will be stratified according to the participating hospital. Patients will be randomized to one of the treatment arms. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Esophagectomy, 5-fluorouracil and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 20 Oct 2017to 31 Dec 2033
- Phase
- Interventional
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years and < 80 years
- Histologically confirmed squamous cell carcinoma of the esophagus
- Clinical stage as cT1N0M0 (AJCC/UICC 7th Edition) according to upper GI endoscopy or endoscopic ultrasound and chest computed tomography (CT) scans
- Pathologic examination after endoscopic submucosal dissection confirmed the presence of submucosal invasion (pathologic T1b) or lymphovascular invasion
- For participants with multiple lesions, all of them should be resected with endoscopic submucosal dissection and at least one lesion should have pathologic submucosal invasion (pT1b) or lymphovascular invasion
- Participants has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1000/µL, hemoglobin ≥8 g/dL, and platelets ≥85,000/µL
- Participants has adequate hepatic and renal function as defined by aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 times the upper limit of normal ; a total bilirubin ≤1.5 times the upper limit of normal ; creatinine clearance ≥ 30mL/min/1.73m2
- Participants should agree to participate in the study and sign the informed consent form
Who cannot join
- Cervical esophageal cancer (proximal to 20cm from incisor teeth)
- Regional lymph node metastasis (cN+) or distant metastasis (cM1) are suspected or confirmed on chest CT scans or positron emission tomography (PET)/CT scans (Equivocal results will be regarded as no metastasis. However, it can also perform a biopsy if necessary (optional))
- Recurrent esophageal cancer
- Uncontrolled systemic disease which makes participants medically unfit for additional treatment (esophagectomy or concurrent chemoradiotherapy) such as congestive heart failure, interstitial lung disease, severe pulmonary emphysema or chronic renal failure
- Gastric conduit is not available for esophageal reconstruction (ex.: previous history of gastrectomy)
- Synchronous or metachronous multiple cancers (within the past 3 years) with the exclusion of skin cancer, well differentiated thyroid cancer, carcinoma in situ, early cancer achieving curative endoscopic resection, or low grade prostate cancer (Gleason Score≤6)
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
National Cancer Center
Goyang-si
Pusan National University Hospital
Pusan, 06351
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Gangnam Severance Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Seoul St. Mary's Hospital
Seoul
About this study
Official title: A Randomized Multicenter Noninferiority Trial Comparing Chemoradiotherapy Versus Esophagectomy After Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Cell Carcinoma (ASSURE)
This is a randomized noninferiority multicenter trial. Patients will be stratified according to the participating hospital. Patients will be randomized to one of the treatment arms.
Arm A: Patients will receive surgical resection, including Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy.
Read more
Arm B: Patients will receive 5-fluorouracil (5-FU) and cisplatin-based chemotherapy concurrently with radiotherapy. Patients will receive cisplatin (45~60mg/m2) intravenously over 1 hour on day 1 and receive 5-FU (3,200 ~ 4,000mg/m2) intravenously for 4 to 5 days. Treatment will repeat every 3 weeks for 2 courses. Patients will receive a total of 45 Gy irradiation (5 days a week for 5 weeks).
Patients will be followed at 3 and 6 months after randomization, then every 6 months for following 2 and half years (up to 3 years after randomization), and 4 and 5 years after randomization. After 5 years, annual follow-up is scheduled up to 10 years after randomization.
We will analyze the results primarily with the intention-to-treatment(ITT) analysis, and then secondarily with the per-protocol(PP) analysis as well.
Read the detailed description
- Compare 1-year, 2-year, 3-year, 5-year, 6-year, 7-year, 8-year, 9-year, 10-year overall survival between concurrent chemoradiotherapy and esophagectomy among patients who require additional treatment for esophageal squamous cell carcinoma endoscopically resected but found to have pT1b (submucosal invasion) or lymphovascular invasion
- Compare 1-year, 2-year, 3-year, 5-year, 6-year, 7-year, 8-year, 9-year, 10-year disease-free survival between concurrent chemoradiotherapy and esophagectomy in the same study population
- Compare quality of life between concurrent chemoradiotherapy and esophagectomy in the same study population
- Compare treatment-related adverse event between concurrent chemoradiotherapy and esophagectomy in the same study population
- Conditions
- Esophageal Cancer
- Being tested
- Esophagectomy, 5-fluorouracil, Cisplatin, Radiation therapy
- 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
Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy
5-fluorouracilDrug
Also called 5-FU
3,200 ~ 4,000mg/m2 intravenously for 4 to 5 days.
CisplatinDrug
45~60mg intravenously over 1 hour on day 1
Radiation therapyRadiation
45 Gy irradiation (5 days a week for 5 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Concurrent Chemoradiotherapy | Experimental | Patients receive 2 courses (every 3 weeks) of chemotherapy including cisplatin (45-60mg/m2) intravenously over 1 hour on day 1 and 5-fluorouracil (3,200 ~ 4,000mg/m2) intravenously for 4 to 5 days.
Patients receive a total of 45 Gy radiation therapy (5 days a week for 5 weeks). Receives: Drug: 5-fluorouracil; Drug: Cisplatin; Radiation: Radiation therapy |
| Esophagectomy | Active comparator | Patients receive surgical resection, including Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy. Receives: Procedure: Esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival
defined as the time from randomization to the date of death from any cause or the last follow-up
Measured: 3 years from the randomization (will be assessed up to 36 months)
Secondary outcomes (9)
Overall survival
defined as the time from randomization to the date of death from any cause or the last follow-up
Measured: 1 year, 2 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years from the randomization (will be assessed up to 60 months)
Disease-free survival
defined as the time from randomization to the first recurrence or the date of death from any cause or the last follow-up
Measured: 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years from the randomization (will be assessed up to 60 months)
Quality of life (Cancer patient-specific)
assessed by EORTC QLQ C-30
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Esophageal cancer-specific symptom)
assessed by EORTC QLQ EOS-18
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Gastrointestinal symptom)
assessed by GSRS
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Depression)
assessed by PHQ-9
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Sleep disorder)
assessed by PSQI
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Fatigue)
assessed by BFI
Measured: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Treatment-related complications or adverse events
assessed by NCI CTCAE ver 4.0
Measured: from treatment to the date of death from any cause or last follow-up (will be assessed up to 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start20 Oct 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2033 (estimated)
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.
- More trials run by Samsung Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Responsible party
- Principal investigator, Hong Kwan Kim, Samsung Medical Center
- Investigators
- Hong Kwan Kim, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306901
- Sponsor's protocol ID
- 2017-04-074
- Acronym
- ASSURE
- Status last verified
- May 2024
- First submitted
- 30 Sep 2017
- Last updated
- 23 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Multicenter Noninferiority Trial Comparing Chemoradiotherapy Versus Esophagectomy After Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Cell Carcinoma (ASSURE)
- ClinicalTrials.gov ID
- NCT03306901
- Acronym / sponsor ID
- ASSURE / 2017-04-074
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health & Welfare, Korea
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 11 Oct 2017 (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 randomized noninferiority multicenter trial. Patients will be stratified according to the participating hospital. Patients will be randomized to one of the treatment arms.
Arm A: Patients will receive surgical resection, including Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy.
Arm B: Patients will receive 5-fluorouracil (5-FU) and cisplatin-based chemotherapy concurrently with radiotherapy. Patients will receive cisplatin (45~60mg/m2) intravenously over 1 hour on day 1 and receive 5-FU (3,200 ~ 4,000mg/m2) intravenously for 4 to 5 days. Treatment will repeat every 3 weeks for 2 courses. Patients will receive a total of 45 Gy irradiation (5 days a week for 5 weeks).
Patients will be followed at 3 and 6 months after randomization, then every 6 months for following 2 and half years (up to 3 years after randomization), and 4 and 5 years after randomization. After 5 years, annual follow-up is scheduled up to 10 years after randomization.
We will analyze the results primarily with the intention-to-treatment(ITT) analysis, and then secondarily with the per-protocol(PP) analysis as well.
Detailed description
- Compare 1-year, 2-year, 3-year, 5-year, 6-year, 7-year, 8-year, 9-year, 10-year overall survival between concurrent chemoradiotherapy and esophagectomy among patients who require additional treatment for esophageal squamous cell carcinoma endoscopically resected but found to have pT1b (submucosal invasion) or lymphovascular invasion
- Compare 1-year, 2-year, 3-year, 5-year, 6-year, 7-year, 8-year, 9-year, 10-year disease-free survival between concurrent chemoradiotherapy and esophagectomy in the same study population
- Compare quality of life between concurrent chemoradiotherapy and esophagectomy in the same study population
- Compare treatment-related adverse event between concurrent chemoradiotherapy and esophagectomy in the same study population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent Chemoradiotherapy | Experimental | Drug: 5-fluorouracil, Drug: Cisplatin, Radiation: Radiation therapyPatients receive 2 courses (every 3 weeks) of chemotherapy including cisplatin (45-60mg/m2) intravenously over 1 hour on day 1 and 5-fluorouracil (3,200 ~ 4,000mg/m2) intravenously for 4 to 5 days. Patients receive a total of 45 Gy radiation therapy (5 days a week for 5 weeks). |
| Esophagectomy | Active comparator | Procedure: EsophagectomyPatients receive surgical resection, including Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 19 years and < 80 years
- Histologically confirmed squamous cell carcinoma of the esophagus
- Clinical stage as cT1N0M0 (AJCC/UICC 7th Edition) according to upper GI endoscopy or endoscopic ultrasound and chest computed tomography (CT) scans
- Pathologic examination after endoscopic submucosal dissection confirmed the presence of submucosal invasion (pathologic T1b) or lymphovascular invasion
- For participants with multiple lesions, all of them should be resected with endoscopic submucosal dissection and at least one lesion should have pathologic submucosal invasion (pT1b) or lymphovascular invasion
Key exclusion criteria (6 listed)
- Cervical esophageal cancer (proximal to 20cm from incisor teeth)
- Regional lymph node metastasis (cN+) or distant metastasis (cM1) are suspected or confirmed on chest CT scans or positron emission tomography (PET)/CT scans (Equivocal results will be regarded as no metastasis. However, it can also perform a biopsy if necessary (optional))
- Recurrent esophageal cancer
- Uncontrolled systemic disease which makes participants medically unfit for additional treatment (esophagectomy or concurrent chemoradiotherapy) such as congestive heart failure, interstitial lung disease, severe pulmonary emphysema or chronic renal failure
- Gastric conduit is not available for esophageal reconstruction (ex.: previous history of gastrectomy)
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 |
|---|---|---|
| EsophagectomyIvor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy | Procedure or surgery | Esophagectomy |
| 5-fluorouracilAlso: 5-FU3,200 ~ 4,000mg/m2 intravenously for 4 to 5 days. | Drug | Concurrent Chemoradiotherapy |
| Cisplatin45~60mg intravenously over 1 hour on day 1 | Drug | Concurrent Chemoradiotherapy |
| Radiation therapy45 Gy irradiation (5 days a week for 5 weeks) | Radiation | Concurrent Chemoradiotherapy |
Primary outcome
3-year overall survival
Time frame: 3 years from the randomization (will be assessed up to 36 months)
defined as the time from randomization to the date of death from any cause or the last follow-up
9 secondary outcomes
Overall survival
Time frame: 1 year, 2 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years from the randomization (will be assessed up to 60 months)
Disease-free survival
Time frame: 1 year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years from the randomization (will be assessed up to 60 months)
Quality of life (Cancer patient-specific)
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Esophageal cancer-specific symptom)
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Gastrointestinal symptom)
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Depression)
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Sleep disorder)
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Quality of life (Fatigue)
Time frame: Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Treatment-related complications or adverse events
Time frame: from treatment to the date of death from any cause or last follow-up (will be assessed up to 60 months)
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 23 May 2024.
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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.
Hong Kwan Kim, MD, PhD principal investigator
Samsung Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esophagectomy, 5-fluorouracil and Cisplatin in people with Esophageal Cancer, run by Samsung Medical Center at 9 sites in South Korea.
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 8 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. 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?
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?
3-year overall survival (time frame: 3 years from the randomization (will be assessed up to 36 months)). 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 23 May 2024.