Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy

Phase 3

• Conditions: Stage III Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Capecitabine(Aibin); Radiation: radiotherapy

• Registration Number: NCT02603159
• Lead Sponsor: The First Affiliated Hospital of Henan University of Science and Technology

Brief Summary

Definitive chemoradiotherapy with cisplatin 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, Capecitabine is widely used in the chemotherapy of esophageal cancer.

The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.

Detailed Description

We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.

Study Timeline

• Study Start: 2014-10
• Status Verified: 2015-10
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-09
• Last Update Submitted: 2015-11-09
• Study First Posted: 2015-11-11
• Last Update Posted: 2015-11-11
• Primary Completion: 2017-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age 45-75years 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Capecitabine-10 weeks-radiotherapy	radiotherapy	Capecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.
Capecitabine-5 weeks-radiotherapy	radiotherapy	Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.
Capecitabine-5 weeks-radiotherapy	Capecitabine(Aibin)	Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.
Capecitabine-10 weeks-radiotherapy	Capecitabine(Aibin)	Capecitabine 10 weeks : 625mg/m2, bid d1-5; q1w, po,10 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.

Primary Outcome Measures

Name	Time	Method
overall survival, OS	2 years

Secondary Outcome Measures

Name	Time	Method
serious adverse event	16 weeks
quality of life, Qol	16 weeks
pathologic complete response rate	16 weeks
progression-free survival	2 years
overall remission rate, ORR	16 weeks

Trial Locations

Locations (1)

The First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China