The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Henan University of Science and Technology
• Collaborators: Anyang Tumor Hospital; No. 150 Central Hospital of the Chinese People Liberation Army; The First Affiliated Hospital of Zhengzhou University; Xinyang Central Hospital
• Treatments: Capecitabine; Oxaliplatin

Criteria

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.