NCT02603159

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 11, 2015

Status Verified

October 1, 2015

Enrollment Period

3.2 years

First QC Date

November 9, 2015

Last Update Submit

November 9, 2015

Conditions

Stage III Esophageal Squamous Cell CarcinomaStage II Esophageal Squamous Cell Carcinoma

Keywords

ChemoradiotherapyEsophageal Squamous CancerCapecitabine

Outcome Measures

Primary Outcomes (1)

  • overall survival, OS

    2 years

Secondary Outcomes (5)

  • progression-free survival

    2 years

  • overall remission rate, ORR

    16 weeks

  • serious adverse event

    16 weeks

  • quality of life, Qol

    16 weeks

  • pathologic complete response rate

    16 weeks

Study Arms (2)

Capecitabine-5 weeks-radiotherapy

EXPERIMENTAL

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

Drug: Capecitabine(Aibin)Radiation: radiotherapy

Capecitabine-10 weeks-radiotherapy

ACTIVE COMPARATOR

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

Drug: Capecitabine(Aibin)Radiation: radiotherapy

Interventions

Capecitabine(Aibin)DRUG

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

Also known as: Aibin
Capecitabine-10 weeks-radiotherapyCapecitabine-5 weeks-radiotherapy
radiotherapyRADIATION

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

Also known as: radiation therapy
Capecitabine-10 weeks-radiotherapyCapecitabine-5 weeks-radiotherapy

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, 471003, China

RECRUITING

Related 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.

    PMID: 20888705BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellEsophageal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Shegan Gao, Doctor

    The First Affiliated Hospital of Henan University of Science and Technology

    STUDY CHAIR

  • Tanyou Shan, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    STUDY DIRECTOR

  • Xiaoshan Feng, Doctor

    The First Affiliated Hospital of Henan University of Science and Technology

    STUDY DIRECTOR

  • Jiachun Sun, Doctor

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Xinshuai Wang, Doctor

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Guoqiang Kong, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Xiaozhi Yuan, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Ruinuo Jia, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Dan Zhuo, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Jing Ren, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Ruina Yang, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Yali Zhang, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Yongxuan Liu, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Wei Wang, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Dan Wang, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Weijiao Yin, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Shiyuan Song, Master

    The First Affiliated Hospital of Henan University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shegan Gao, Doctor

CONTACT

18638859977gsg112258@163.com

Tanyou Shan, Master

CONTACT

18537976669shantanyou@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2015

First Posted

November 11, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2019

Last Updated

November 11, 2015

Record last verified: 2015-10

Locations

CN(1)