Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Esophagectomy | Active Comparator | Patients receive surgical resection, including Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagectomy | Procedure | Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival | defined as the time from randomization to the date of death from any cause or the last follow-up | 3 years from the randomization (will be assessed up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | defined as the time from randomization to the date of death from any cause or the last follow-up | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hong Kwan Kim, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | South Korea | ||||
| Pusan National University Hospital |
Not provided
Not provided
Not provided
Not provided
Outcome assessors and data analysists will be blinded
| 5-fluorouracil | Drug | 3,200 ~ 4,000mg/m2 intravenously for 4 to 5 days. |
|
|
| Cisplatin | Drug | 45~60mg intravenously over 1 hour on day 1 |
|
| Radiation therapy | Radiation | 45 Gy irradiation (5 days a week for 5 weeks) |
|
defined as the time from randomization to the first recurrence or the date of death from any cause or the last follow-up |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | from treatment to the date of death from any cause or last follow-up (will be assessed up to 60 months) |
| Pusan |
| 06351 |
| South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Seoul St. Mary's Hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016629 | Esophagectomy |
| D005472 | Fluorouracil |
| D002945 | Cisplatin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D013812 | Therapeutics |
Not provided
Not provided