Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy

Stage III Esophageal Squamous Cell Carcinoma Clinical Trial

— DCECRT  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02603159
• Other study ID #: Capecitabine and esophageal
• Status: Recruiting
• Phase: Phase 3
• First received: November 9, 2015
• Last updated: November 9, 2015
• Start date: October 2014
• Est. completion date: December 2019

Study information

• Verified date: October 2015
• Source: The First Affiliated Hospital of Henan University of Science and Technology
• Contact: Shegan Gao, Doctor
• Phone: 18638859977
• Email: gsg112258[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Neoplasms
• Stage II Esophageal Squamous Cell Carcinoma
• Stage III Esophageal Squamous Cell Carcinoma

Intervention

Drug:
• Capecitabine(Aibin)
Capecitabine(Aibin):625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Henan University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (1)

Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival, OS		2 years	Yes
Secondary	progression-free survival		2 years	Yes
Secondary	overall remission rate, ORR		16 weeks	Yes
Secondary	serious adverse event		16 weeks	Yes
Secondary	quality of life, Qol		16 weeks	No
Secondary	pathologic complete response rate		16 weeks	No