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Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma (ASSURE)

Primary Purpose

Esophageal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Esophagectomy
5-fluorouracil
Cisplatin
Radiation therapy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 19 years and < 80 years
  2. Histologically confirmed squamous cell carcinoma of the esophagus
  3. Clinical stage as cT1N0M0 (AJCC/UICC 7th Edition) according to upper GI endoscopy or endoscopic ultrasound and chest computed tomography (CT) scans
  4. Pathologic examination after endoscopic submucosal dissection confirmed the presence of submucosal invasion (pathologic T1b) or lymphovascular invasion
  5. 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
  6. Participants has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥1000/µL, hemoglobin ≥8 g/dL, and platelets ≥85,000/µL
  7. 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
  8. Participants should agree to participate in the study and sign the informed consent form

Exclusion Criteria:

  1. Cervical esophageal cancer (proximal to 20cm from incisor teeth)
  2. 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))
  3. Recurrent esophageal cancer
  4. 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
  5. Gastric conduit is not available for esophageal reconstruction (ex.: previous history of gastrectomy)
  6. 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)

Sites / Locations

  • National Cancer CenterRecruiting
  • Pusan National University HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Asan Medical CenterRecruiting
  • Gangnam Severance HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • Seoul National University HospitalRecruiting
  • Seoul St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Concurrent Chemoradiotherapy

Esophagectomy

Arm Description

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).

Patients receive surgical resection, including Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy.

Outcomes

Primary Outcome Measures

3-year overall survival
defined as the time from randomization to the date of death from any cause or the last follow-up

Secondary Outcome Measures

Overall survival
defined as the time from randomization to the date of death from any cause or the last follow-up
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
Quality of life (Cancer patient-specific)
assessed by EORTC QLQ C-30
Quality of life (Esophageal cancer-specific symptom)
assessed by EORTC QLQ EOS-18
Quality of life (Gastrointestinal symptom)
assessed by GSRS
Quality of life (Depression)
assessed by PHQ-9
Quality of life (Sleep disorder)
assessed by PSQI
Quality of life (Fatigue)
assessed by BFI
Treatment-related complications or adverse events
assessed by NCI CTCAE ver 4.0

Full Information

First Posted
September 30, 2017
Last Updated
January 16, 2023
Sponsor
Samsung Medical Center
Collaborators
Ministry of Health & Welfare, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03306901
Brief Title
Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma
Acronym
ASSURE
Official Title
A Randomized Multicenter Noninferiority Trial Comparing Chemoradiotherapy Versus Esophagectomy After Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Cell Carcinoma (ASSURE)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Ministry of Health & Welfare, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors and data analysists will be blinded
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Concurrent Chemoradiotherapy
Arm Type
Experimental
Arm Description
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).
Arm Title
Esophagectomy
Arm Type
Active Comparator
Arm Description
Patients receive surgical resection, including Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy.
Intervention Type
Procedure
Intervention Name(s)
Esophagectomy
Intervention Description
Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil
Other Intervention Name(s)
5-FU
Intervention Description
3,200 ~ 4,000mg/m2 intravenously for 4 to 5 days.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
45~60mg intravenously over 1 hour on day 1
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
45 Gy irradiation (5 days a week for 5 weeks)
Primary Outcome Measure Information:
Title
3-year overall survival
Description
defined as the time from randomization to the date of death from any cause or the last follow-up
Time Frame
3 years from the randomization (will be assessed up to 36 months)
Secondary Outcome Measure Information:
Title
Overall survival
Description
defined as the time from randomization to the date of death from any cause or the last follow-up
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)
Title
Disease-free survival
Description
defined as the time from randomization to the first recurrence or the date of death from any cause or the last follow-up
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)
Title
Quality of life (Cancer patient-specific)
Description
assessed by EORTC QLQ C-30
Time Frame
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Title
Quality of life (Esophageal cancer-specific symptom)
Description
assessed by EORTC QLQ EOS-18
Time Frame
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Title
Quality of life (Gastrointestinal symptom)
Description
assessed by GSRS
Time Frame
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Title
Quality of life (Depression)
Description
assessed by PHQ-9
Time Frame
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Title
Quality of life (Sleep disorder)
Description
assessed by PSQI
Time Frame
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Title
Quality of life (Fatigue)
Description
assessed by BFI
Time Frame
Baseline, 3 months, 6 months, 1 year, 2 years, 3 years from treatment (will be assessed up to 36 months)
Title
Treatment-related complications or adverse events
Description
assessed by NCI CTCAE ver 4.0
Time Frame
from treatment to the date of death from any cause or last follow-up (will be assessed up to 60 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Kwan Kim, MD, PhD
Phone
+82-2-3410-1687
Email
hkts.kim@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Genehee Lee, APN, MSN
Phone
+82-2-3410-1062
Email
genehee.lee@samsung.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Kwan Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jong Mog Lee, MD, PhD
Email
jongmog@ncc.re.kr
Facility Name
Pusan National University Hospital
City
Pusan
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hoseok I, MD,PhD
Email
ihoseok@hotmail.com
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwhan-Mien Kim, MD, PhD
Email
kmkim0070@snubh.org
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hwoon-Yong Jung, MD, PhD
Email
hyjung@amc.seoul.kr
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sungsoo Lee, MD, PhD
Email
chestlee@yuhs.ac
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyun Koo Kim, MD, PhD
Email
kimhyunkoo@korea.ac.kr
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Kwan Kim, MD, PhD
Email
hkts.kim@samsung.com
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Hyun Kang, MD, PhD
Email
chkang@snu.ac.kr
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Myung Park, MD, PhD
Email
parkjerry@catholic.ac.kr

12. IPD Sharing Statement

Learn more about this trial

Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma

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