Esophagectomy
ProcedureIvor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy
NCT Number: NCT03306901
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.
This study is active but is not currently recruiting participants.
Notify Me19 year–79 year
All sexes
Interventional
Not applicable
National Cancer Center, Goyang-si, South Korea
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy
3,200 ~ 4,000mg/m2 intravenously for 4 to 5 days.
Other names: 5-FU
45~60mg intravenously over 1 hour on day 1
45 Gy irradiation (5 days a week for 5 weeks)
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
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
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
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
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
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
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
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
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
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
Samsung Medical Center
Other
A Randomized Multicenter Noninferiority Trial Comparing Chemoradiotherapy Versus Esophagectomy After Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Cell Carcinoma (ASSURE)
Acronym: ASSURE
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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