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Trial Title:
Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer
NCT ID:
NCT02025036
Condition:
Stage III Esophageal Squamous Cell Carcinoma
Stage II Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Capecitabine
Oxaliplatin
Conditions: Keywords:
Chemoradiotherapy， Esophageal Squamous Cancer
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Capecitabine(Aibin)
Description:
capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total
Arm group label:
Capecitabine and radiotherapy
Arm group label:
Capecitabine-oxaliplatin-radiotherapy
Other name:
Aibin
Intervention type:
Drug
Intervention name:
Oxaliplatin(Aiheng)
Description:
Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.
Arm group label:
Capecitabine-oxaliplatin-radiotherapy
Other name:
Aiheng
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or
unacceptable toxicity
Arm group label:
Capecitabine and radiotherapy
Arm group label:
Capecitabine-oxaliplatin-radiotherapy
Arm group label:
cisplatin with 5-FU and radiotherapy
Other name:
Radiation Therapy
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Henan University of Science and Technology
Address:
City:
Luoyang
Zip:
471003
Country:
China
Start date:
October 2014
Completion date:
April 1, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Henan University of Science and Technology
Agency class:
Other
Collaborator:
Agency:
Luoyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Military 150 Hospital
Agency class:
Other
Collaborator:
Agency:
Anyang Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
Nanyang Central Hospital
Agency class:
Other
Collaborator:
Agency:
Henan Oncology Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Xinyang Medical College
Agency class:
Other
Collaborator:
Agency:
Sanmenxia Central Hospital
Agency class:
Other
Source:
The First Affiliated Hospital of Henan University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02025036
