Active, not recruitingNCT03306901ASSUREUpdated May 23, 2024

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

An interventional study of Esophagectomy and 5-fluorouracil in Esophageal Cancer, sponsored by Samsung Medical Center. Active, not recruiting at 9 sites in Korea, Republic of. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 240
Allocation: Randomized
Ages: 19 Years to 79 Years
Sex: All

Study 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.

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 studied

Esophageal Cancer

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Who can participate

Ages eligible: 19 Years to 79 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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)

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 240 participants (estimated)

Study arms

Experimental
Concurrent Chemoradiotherapy
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).
Drug: 5-fluorouracil · Drug: Cisplatin · Radiation: Radiation therapy
Active comparator
Esophagectomy
Patients receive surgical resection, including Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy.
Procedure: Esophagectomy

Interventions

ProcedureEsophagectomy
Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy
Drug5-fluorouracil
3,200 \~ 4,000mg/m2 intravenously for 4 to 5 days.
Also known as: 5-FU
DrugCisplatin
45\~60mg intravenously over 1 hour on day 1
RadiationRadiation therapy
45 Gy irradiation (5 days a week for 5 weeks)

What researchers measure

Primary outcomes

3-year overall survival
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 outcomes

Overall survival
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)
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
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)
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)
Quality of life (Esophageal cancer-specific symptom)
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)
Quality of life (Gastrointestinal symptom)
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)
Quality of life (Depression)
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)
Quality of life (Sleep disorder)
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)
Quality of life (Fatigue)
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)
Treatment-related complications or adverse events
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)

Study locations

9 sites

National Cancer Center
Goyang-si, Korea, Republic of
Pusan National University Hospital
Pusan, 06351, Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of

Registry details

Key details

Study ID: NCT03306901
Lead sponsor: Samsung Medical Center
Collaborators: Ministry of Health & Welfare, Korea
Responsible party: Hong Kwan Kim (Chief of Department of General Thoracic Surgery, Samsung Medical Center) — Principal investigator
First posted: Oct 11, 2017
Start date: Oct 20, 2017
Primary completion: Dec 31, 2025 (estimated)
Completion: Dec 31, 2033 (estimated)
Last update: May 23, 2024

Study contacts

Hong Kwan Kim, MD, PhD

principal investigator · Samsung Medical Center

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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