search
Back to results

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

Primary Purpose

Esophageal Carcinoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
placebo
Sodium Glycididazole
Sponsored by
Shandong Luye Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Carcinoma focused on measuring Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beijing Cancer HospitalRecruiting
  • Cancer Center of Sun Yat-sen UniversityRecruiting
  • Zhongshan Hospital of Fudan UniversityRecruiting
  • Cancer Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Concurrent radiochemotherapy and placebo

concurrent radiochemotherapy and Sodium Glycididazole

Outcomes

Primary Outcome Measures

tumour local control rate

Secondary Outcome Measures

survival rate

Full Information

First Posted
March 21, 2008
Last Updated
May 13, 2008
Sponsor
Shandong Luye Pharmaceutical Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00642239
Brief Title
A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma
Official Title
A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shandong Luye Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Carcinoma
Keywords
Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Concurrent radiochemotherapy and placebo
Arm Title
1
Arm Type
Experimental
Arm Description
concurrent radiochemotherapy and Sodium Glycididazole
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Sodium Glycididazole
Other Intervention Name(s)
CMNa
Intervention Description
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.
Primary Outcome Measure Information:
Title
tumour local control rate
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
survival rate
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lvhua Wang, Doctor
Phone
86-10-87788503
Email
wlhwq@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Liang, Doctor
Phone
86-10-87788503
Email
lj139117@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lvhua Wang, Doctor
Organizational Affiliation
Cancer Hospital, Chinese Academy of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100036
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bo Xu, Doctor
Phone
8610-88196170
Email
fangliaoxubo@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Bo Xu, Doctor
Facility Name
Cancer Center of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengzhong Liu, Doctor
Phone
8620-83743371
Email
lmz1955@163.com
First Name & Middle Initial & Last Name & Degree
Mengzhong Liu, Doctor
Facility Name
Zhongshan Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengying Wang, Doctor
Phone
8621-64160820
First Name & Middle Initial & Last Name & Degree
FengYing Wang, Doctor
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lvhua Wang, Doctor
Phone
86-10-87788503
Email
wlhwq@yahoo.com
First Name & Middle Initial & Last Name & Degree
Jun Liang, Doctor
Phone
86-10-87788503
Email
lj139117@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Lvhua Wang, Doctor

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs