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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

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