Esophageal Neoplasms Clinical Trial
— DCOECRTOfficial title:
Two Cycles Versus Four Cycles of Capecitabine Combined Oxaliplatin Concurrent Radiotherapy as First-line Therapy for Chinese Locally Advanced Esophageal Squamous Cell Carcinomas, an Open Randomised Phase III Cilinical Trial
A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent
radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive
chemoradiotherapy is the standard regimen in Western countries for patients with esophageal
cancer who can't receive surgery or reject surgery. But in China because of its severer
toxic reaction, most of patients had to discontinue treatment at the halfway way. Thus, the
chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to
its characristic of low toxic reaction.
The purpose of this study is to confirm the efficacy and safety of the different cycles(two
cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous
carcinoma radical concurrent chemoradiotherapy. A total of 60 patients will be accrued from
China within 2 years. The primary endpoint is overall survival and the secondary endpoints
include progression-free survival, response rate, pathologic complete response rate and
adverse events.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2020 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Voluntary participation and signed a consent form - Histologically proven squamous cell carcinoma of the esophagus, initial treatment (Not had surgery, radiotherapy, chemotherapy or targeted therapy) - the tumor was in T2-4N0-2M0, locally advanced(AJCC2002) - Have a measurable lesions. - Male or female who has fertility is willing to take contraceptive measures in the experiment - WBC=3x10 9/L;Hb=80g/L;ANC =1.5x10 9/L;PLT =100x10 9/L;TBIL< 1.5xN;AST (SGOT)/ALT (SGPT) =2.5xN;Cr=1.5xN. - Performance status score 0-2 - Expected lifetime>3 months Exclusion Criteria: - Pregnant, lactating women or With fertility but did not use contraceptive measures - Has a history of severe allergic or idiosyncrasy - Hab been treated with surgery, radiation and chemotherapy or targeted therapy for esophageal cancer - After exploratory thoracotomy or Laying an esophageal tracheal stent - Received a major surgery treatment within 28 days prior to the start of research and treatment - History of organ transplantation - Has uncontrolled seizures or Lose self-knowledge because of mental illness - Severe infection - Oral capecitabine who have difficulty with,such as esophageal obstructed completely, 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Henan University of Science and Technology | Anyang Tumor Hospital, No. 150 Central Hospital of the Chinese People Liberation Army, The First Affiliated Hospital of Zhengzhou University, Xinyang Central Hospital |
China,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall survival, OS | 2 years | Yes | |
Secondary | progression-free survival,PFS | 2 years | Yes | |
Secondary | overall remission rate, ORR | 16 weeks | No | |
Secondary | serious adverse event,SAE | 16 weeks | Yes | |
Secondary | quality of life, Qol | 16 weeks | No | |
Secondary | pathologic complete response rate | 16 weeks | No | |
Secondary | disease control rate,DCR | 16 weeks | No |
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