A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma
A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma
1 other identifier
interventional
48
1 country
4
Brief Summary
This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2008
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedMay 14, 2008
May 1, 2008
8 months
March 21, 2008
May 13, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tumour local control rate
6 weeks
Secondary Outcomes (1)
survival rate
one year
Study Arms (2)
2
PLACEBO COMPARATORConcurrent radiochemotherapy and placebo
1
EXPERIMENTALconcurrent radiochemotherapy and Sodium Glycididazole
Interventions
placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100036, China
Cancer Center of Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032, China
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lvhua Wang, Doctor
Cancer Hospital Chinese Academy of Medical Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 25, 2008
Study Start
April 1, 2008
Primary Completion
December 1, 2008
Study Completion
December 1, 2009
Last Updated
May 14, 2008
Record last verified: 2008-05