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NCT Number: NCT03306901

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center, Goyang-si, South Korea

Loading trial locations.

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Esophagectomy

Procedure

Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy

5-fluorouracil

Drug

3,200 ~ 4,000mg/m2 intravenously for 4 to 5 days.

Other names: 5-FU

Cisplatin

Drug

45~60mg intravenously over 1 hour on day 1

radiation therapy

Radiation

45 Gy irradiation (5 days a week for 5 weeks)

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

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

  2. 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)

    defined as the time from randomization to the first recurrence or the date of death from any cause or the last follow-up

  3. 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)

    assessed by EORTC QLQ C-30

  4. 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)

    assessed by EORTC QLQ EOS-18

  5. 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)

    assessed by GSRS

  6. 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)

    assessed by PHQ-9

  7. 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)

    assessed by PSQI

  8. 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)

    assessed by BFI

  9. 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)

    assessed by NCI CTCAE ver 4.0

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Official study title

A Randomized Multicenter Noninferiority Trial Comparing Chemoradiotherapy Versus Esophagectomy After Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Cell Carcinoma (ASSURE)

Acronym: ASSURE

Important dates

Study start
2017
Primary completion
2025
Study completion
2033
First posted
Oct 11, 2017
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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