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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00642239

Enrollment

Registered

2008-03-25

Start date

2008-04-30

Completion date

2009-12-31

Last updated

2008-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Carcinoma

Keywords

Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma

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.

Interventions

DRUGplacebo

placebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks.

DRUGSodium 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
tumour local control rate	6 weeks

Secondary

Measure	Time frame
survival rate	one year

Countries

China

Contacts

Primary ContactLvhua Wang, Doctor

wlhwq@yahoo.com86-10-87788503

Backup ContactJun Liang, Doctor

lj139117@yahoo.com.cn86-10-87788503

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026