A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma

May 13, 2008 updated by: Shandong Luye Pharmaceutical Co., Ltd.

A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma

This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Esophageal cancer is one of the most frequent causes of cancer death in the world. The most common type of esophageal cancer is squamous cell carcinoma (SCC) in China. Although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%.

Sodium Glycididazole(CMNa) is a radiosensitive drug for hypoxic tumor cells. Clinical trials showed that CMNa can improve local control rate and survival rate of esophageal cancer. This study is going to confirm the efficacy and safety of CMNa in concurrent radiochemotherapy of radiotherapy and 5-FU+DDP for esophageal squamous carcinoma.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 4

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

  • Name: Lvhua Wang, Doctor
  • Phone Number: 86-10-87788503
  • Email: wlhwq@yahoo.com

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100021
        • Recruiting
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lvhua Wang, Doctor
    • Beijing
      • Beijing, Beijing, China, 100036
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Bo Xu, Doctor
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Cancer center of Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Mengzhong Liu, Doctor
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital of Fudan University
        • Contact:
          • Fengying Wang, Doctor
          • Phone Number: 8621-64160820
        • Principal Investigator:
          • FengYing Wang, Doctor

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • written informed consent
  • photographically and histologically proven thoracic esophageal squamous carcinoma
  • stages 2a-3, and stage 4 with only supraclavicular lymph nodes metastasis defined by AJCC(2002)
  • radiochemotherapy indication
  • measurable tumor
  • adequate hematologic, hepatic and renal function
  • Karnofsky performance status ≥70
  • age more than 18years and less than 70 years

Exclusion Criteria:

  • pregnancy and lactation
  • significant neurologic disease
  • severe liver and renal malfunction,and Significant medical illness
  • previous chemotherapy, radiotherapy or immunotherapy
  • esophagus hemorrhage and esophagus perforation features

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Concurrent radiochemotherapy and placebo
Drug: placebo
placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
Experimental: 1
concurrent radiochemotherapy and Sodium Glycididazole
Drug: Sodium Glycididazole
Sodium Glycididazole 700mg/m2 in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
Other Names:
  • CMNa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
tumour local control rate
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
survival rate
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

Shandong Luye Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Lvhua Wang, Doctor, Cancer Hospital, Chinese Academy of Medical Science

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

April 1, 2008

Primary Completion (Anticipated)

December 1, 2008

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

March 21, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Estimate)

May 14, 2008

Last Update Submitted That Met QC Criteria

May 13, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMNa-ESO-01-2007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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