Esophagus Cancer
Conditions
Keywords
esophageal cancer, chemoradiation, esophagectomy
Brief summary
The aim of this study is to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT) by the randomized, open-label, multicenter trial.
Detailed description
Background: More than half of global esophageal cancer cases came from China, but the report about definitive chemoradiation (CRT) compared with esophagectomy in Chinese patients with locally advanced resectable esophageal squamous cell cancer (ESCC) is limited. Aim: to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT). Methods: 176 ESCC patients with T1bN+M0, T2-4aN0-2M0 will be randomized to CRT group or Surgery group.In the CRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50Gy/25 fractions , and current chemotherapy with 5-fluorouracil (5-FU) basic regimens. In the surgery group, patients will received standard esophagectomy. 5 years follow-up for both groups patients. Primary endpoints: 2 year and 5 year Disease free survival, Overall survival Second endpoints: treatment-related adverse events; the quality of life
Interventions
PROCEDURECRT
Drug: Capecitabine(Aibin) capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total Other Names: Aibin Drug: Oxaliplatin(Aiheng) Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V. Other Names: Aiheng cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85. 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88. Radiation: Radiotherapy concurrent radiotherapy：IMRT radiotherapy 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
PROCEDUREsurgery
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Anyang Tumor Hospital
150th Hospital of PLA
The First Affiliated Hospital of Henan University of Science and Technology
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
* Chinese * esophageal squamous cell cancer * mid or lower esophageal cancer * tumor is resectable disease * clinical stage: cT1bN+Mo, or cT2-4aN0-2M0
Exclusion criteria
* who had distant metastasis to solid visceral organs or local invasion into trachea, descending aorta, or recurrent laryngeal nerve. * who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year disease-free survival rate | 2 year | The percent of 2 year disease-free survival after random allocation, percent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-related adverse events | 2 year | The percent of treatment-related adverse events after 2 year random allocation, percent |
| QoF (quality of life) | 2 year | The quality of life evaluation after 2 year of random allocation by questionnaire, 1-10 score, 1 means poor and 10 means best |
| 2 year overall survival | 2 year | The percent of 2 year overall survival after random allocation, percent |
Countries
China
Contacts
Primary ContactShegan Gao, MD, PhD
Backup ContactRuinuo Jia, MD
Outcome results
None listed