MedTrace Logo

Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy

NCT02603159 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-11-11

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Henan University of Science and Technology

    lead OTHER

Principal Investigators

  • Shegan Gao, Doctor · The First Affiliated Hospital of Henan University of Science and Technology

  • Tanyou Shan, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Xiaoshan Feng, Doctor · The First Affiliated Hospital of Henan University of Science and Technology

  • Jiachun Sun, Doctor · The First Affiliated Hospital of Henan University of Science and Technology

  • Xinshuai Wang, Doctor · The First Affiliated Hospital of Henan University of Science and Technology

  • Guoqiang Kong, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Xiaozhi Yuan, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Ruinuo Jia, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Dan Zhuo, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Jing Ren, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Ruina Yang, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Yali Zhang, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Yongxuan Liu, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Wei Wang, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Dan Wang, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Weijiao Yin, Master · The First Affiliated Hospital of Henan University of Science and Technology

  • Shiyuan Song, Master · The First Affiliated Hospital of Henan University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-12-31
Completion
2019-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02603159 on ClinicalTrials.gov