Esophagogastric Junction Disorder, Neoplasms
Conditions
Brief summary
Patients with histologically confirmed esophagogastric junction adenocarcinoma with pre-operative staging cT3-4N+M0，aged between 18-75 years old, with adequate organ function and having an Eastern Cooperative Oncology Group performance status score ≤2, are randomized in a 1:1:1 ratio to receive neoadjuvant chemoradiotherapy with DT46-50Gy plus concomitant weekly oxaliplatin and 5-Fu, perioperative chemotherapy of FLOT regimen or FOLFOX regimen. The primary end point is disease free survival (DFS), and secondary end point is 5-year overall survival (OS), pathological complete remission (pCR) and treatment safety. The final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.
Interventions
RADIATIONchemoradiation with weekly 5Fu and oxaliplatin
5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week
DRUGPerioperative mFLOT
Perioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles
DRUGPerioperative FOLFOX
Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* informed consensus of the enrolled patients * from 18 to 75 years old * proven to be primary adenocarcinoma of EGJ * pre-operative staging cT3-4N+M0 * no prior other chemotherapy and/or radiation against the disease * normal function of all other vital organs including heart,liver ,kidney and so on * Eastern Cooperative Oncology Group performance status: 0\ 2
Exclusion criteria
* history of other malignancy * allergic reaction to capecitabine or oxaliplatin * enrolled in other clinical trials * abnormal GI tract function * dysfunction of other organs * pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy * other situations judged as not adaptive to the study by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year of disease free survival | 3 year |
Secondary
| Measure | Time frame |
|---|---|
| 5 year of overall survival | 5 year |
| Rate of pathological complete remission | 1 year |
| Anastomosis leak rate | 1 year |
Contacts
Primary ContactShanshan Li, MD
Backup ContactXiaohui Zhai, MD
Outcome results
None listed