Back to results

Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy (DCECRT)

Primary Purpose

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

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Capecitabine(Aibin)

radiotherapy

About this trial

This is an interventional treatment trial for Stage III Esophageal Squamous Cell Carcinoma focused on measuring Chemoradiotherapy, Esophageal Squamous Cancer, Capecitabine

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Capecitabine-5 weeks-radiotherapy

Capecitabine-10 weeks-radiotherapy

Arm Description

Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.

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

Outcomes

Primary Outcome Measures

overall survival, OS

Secondary Outcome Measures

progression-free survival

overall remission rate, ORR

serious adverse event

quality of life, Qol

pathologic complete response rate

Full Information

NCT ID

NCT02603159

First Posted

November 9, 2015

Last Updated

November 9, 2015

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT02603159

Brief Title

Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy

Acronym

DCECRT

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Chemoradiotherapy, Esophageal Squamous Cancer, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine-5 weeks-radiotherapy

Arm Type

Experimental

Arm Description

Capecitabine 5 weeks : 625mg/m2, bid d1-5; q1w, po,5 weeks in total, radiotherapy： 50Gy ，2 Gy/d，5d/w.

Arm Title

Capecitabine-10 weeks-radiotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine(Aibin)

Other Intervention Name(s)

Aibin

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Other Intervention Name(s)

radiation therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

overall survival, OS

Time Frame

2 years

Secondary Outcome Measure Information:

Title

progression-free survival

Time Frame

2 years

Title

overall remission rate, ORR

Time Frame

16 weeks

Title

serious adverse event

Time Frame

16 weeks

Title

quality of life, Qol

Time Frame

16 weeks

Title

pathologic complete response rate

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shegan Gao, Doctor

Phone

18638859977

gsg112258@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Tanyou Shan, Master

Phone

18537976669

shantanyou@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shegan Gao, Doctor

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tanyou Shan, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Xiaoshan Feng, Doctor

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Jiachun Sun, Doctor

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xinshuai Wang, Doctor

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Guoqiang Kong, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaozhi Yuan, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ruinuo Jia, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dan Zhuo, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jing Ren, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ruina Yang, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yali Zhang, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yongxuan Liu, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Wei Wang, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dan Wang, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Weijiao Yin, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shiyuan Song, Master

Organizational Affiliation

The First Affiliated Hospital of Henan University of Science and Technology

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Henan University of Science and Technology

City

Luoyang

State/Province

Henan

ZIP/Postal Code

471003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

shegan gao, doctor

Phone

0379 64811906

gsg112258@163.com

First Name & Middle Initial & Last Name & Degree

tanyou shan, master

Phone

0379 64815350

shantanyou@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

20888705

Citation

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.

Results Reference

background

Learn more about this trial

Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy

We'll reach out to this number within 24 hrs