Stage II Esophageal Squamous Cell Carcinoma, Stage III Esophageal Squamous Cell Carcinoma
Conditions
Keywords
Chemoradiotherapy， Esophageal Squamous Cancer
Brief summary
A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway. Because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical. The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.
Detailed description
We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into three groups.Experimental group 1 : single drug Capecitabine and concurrent radiotherapy.Experimental group 2: Capecitabine plus oxaliplatin and concurrent radiotherapy. Control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. To evaluate the adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.
Interventions
capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total
Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.
RADIATIONRadiotherapy
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Sponsors
Luoyang Central Hospital
Military 150 Hospital
Anyang Cancer Hospital
Nanyang Central Hospital
Henan Oncology Hospital
The First Affiliated Hospital of Xinyang Medical College
Sanmenxia Central Hospital
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
* age 18-75years old * Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0 * The patients have not received the surgery or chemo-radiotherapy. * Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L, * ALT、AST≤2.5\*N,Cr≤1.5\*N. * performance status score 0-2
Exclusion criteria
* pregnant, lactating women * Oxaliplatin or fluorouracil Allergy or metabolic disorders * Radiotherapy contraindications * History of organ transplantation * Brain metastasis * The peripheral nervous system disorders * Severe infection * Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding * Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. * Other malignant tumor in recent 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grade 3/5 acute toxicities | 90 days | Grade 3/5 acute toxicities occurred during or within 90 days after RT |
| OS-2 year | 2 years | Overall Survival rate in 2 year from Randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS-2 year | 2 years | Progression Free Survival rate in 2 year from Randomization |
| overall remission rate, ORR | 16 weeks | overall remission rate after CRT |
| quality of life, Qol | 16 weeks | quality of life evaluation |
| pathologic complete response rate | 16 weeks | pathologic complete response rate confirmed by gastroscope biopsy |
Countries
China
Outcome results
None listed