Trial | NCT02025036  Report issue

Title

Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer
Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    249
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.
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.
Study Started
Oct 31
2014
Primary Completion
Sep 13
2022
Study Completion
Apr 01
2025
Anticipated
Last Update
Feb 08
2023

Drug Capecitabine(Aibin)

capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total

  • Other names: Aibin

Drug Oxaliplatin(Aiheng)

Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.

  • Other names: Aiheng

Radiation Radiotherapy

concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

  • Other names: Radiation Therapy

Capecitabine-oxaliplatin-radiotherapy Experimental

oxaliplatin：65mg/m2，d1，8，22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

cisplatin with 5-FU and radiotherapy Active Comparator

cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85, 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Capecitabine and radiotherapy Experimental

capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

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.
No Results Posted