Different Cycles of Cisplatin-5-fluorouracil for the Chemoradiotherapy of Esophageal Squamous Cancer (PFCRTESC)

January 10, 2016 updated by: The First Affiliated Hospital of Henan University of Science and Technology

Two-arm Phase III Trial Comparing Radiotherapy With Differentcycles of Cisplatin-5-fluorouracil for Esophageal Cancer

A two-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy 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.

The purpose of this study is to confirm the difference of 2 and 4 cycles of cisplatin plus 5-fluorouracil in the definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 210 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into two groups.Experimental group: Two cycles of cisplatin plus 5-fluorouracil concurrent radiotherapy.Control group:Four cycles of cisplatin plus 5-fluorouracil and concurrent radiotherapy.To evaluate the overall survival of the 2 group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate and adverse events.

Study Type

Interventional

Enrollment (Anticipated)

210

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Two cycles PF-radiotherapy

2 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32.

radiotherapy： 50Gy，2 Gy/d，5d/w.
Radiation: Radiotherapy
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Other Names:
  • Radiation Therapy
Other: 2 cycles cisplatin-5-fluorouracil
2 cycles cisplatin-5-fluorouracil(PF 2 cycles): cisplatin: 75mg/m2 d1，29; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32.
Other Names:
  • PF 2 cycles
Active Comparator: Four cycles PF-radiotherapy

4 cycles cisplatin-5-fluorouracil: cisplatin: 75mg/m2 d1，29, 57, 85；5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88.

radiotherapy： 50Gy，2 Gy/d，5d/w.
Radiation: Radiotherapy
concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Other Names:
  • Radiation Therapy
Other: 4 cycles cisplatin-5-fluorouracil
4 cycles cisplatin-5-fluoroura(PF 4 cycles): cilcisplatin: 75mg/m2 d1，29, 57, 85; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88.
Other Names:
  • PF 4 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival, OS
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
overall remission rate, ORR
Time Frame: 16 weeks
16 weeks
quality of life, Qol
Time Frame: 16 weeks
16 weeks
pathologic complete response rate
Time Frame: 16 weeks
16 weeks
progression-free survival,PFS
Time Frame: 2 years
2 years
serious adverse event,SAE
Time Frame: 16 weeks
16 weeks
disease control rate,DCR
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Investigators

  • Study Chair: Shegan Gao, Doctor, The First Affiliated Hospital of Henan University of Science and Technology
  • Study Director: 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
  • Principal Investigator: 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: 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: Dan Zhou, Master, The First Affiliated Hospital of Henan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 16, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Estimate)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 10, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PF and esophageal cancer

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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