Esophageal CarcinomaPhase 4NCT00642239
A Clinical Trial of a Radiation Sensitizer in Radiochemotherapy for Thoracic Esophageal Squamous Carcinoma
A Phase 4 study testing Sodium Glycididazole in people with Esophageal Carcinoma, run by Shandong Luye Pharmaceutical Co., Ltd. at 4 sites in China.
Trial summary
This multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Carcinoma
- What is being tested?
- Sodium Glycididazole
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 4 sitesChina
- Study dates
- Apr 2008to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100036
Bo Xu, Doctor, 8610-88196170, fangliaoxubo@vip.sina.com
Bo Xu, Doctor
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, 100021
Lvhua Wang, Doctor, 86-10-87788503, wlhwq@yahoo.com
Jun Liang, Doctor, 86-10-87788503, lj139117@yahoo.com.cn
- Recruiting
Cancer Center of Sun Yat-sen University
Guangzhou, Guangdong, 510060
Mengzhong Liu, Doctor, 8620-83743371, lmz1955@163.com
Mengzhong Liu, Doctor
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Fengying Wang, Doctor, 8621-64160820
FengYing Wang, Doctor
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Carcinoma
- Being tested
- placebo, Sodium Glycididazole
- Keywords
- Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
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 GlycididazoleDrug
Also called CMNa
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 group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Concurrent radiochemotherapy and placebo Receives: Drug: placebo |
| 1 | Experimental | concurrent radiochemotherapy and Sodium Glycididazole Receives: Drug: Sodium Glycididazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumour local control rate
Measured: 6 weeks
Secondary outcomes (1)
survival rate
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Luye Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lvhua Wang, Doctor, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642239
- Sponsor's protocol ID
- CMNa-ESO-01-2007
- Status last verified
- May 2008
- First submitted
- 21 Mar 2008
- Last updated
- 14 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized Clinical Trial of Sodium Glycididazole in Concurrent Radiochemotherapy for the Treatment of Thoracic Esophageal Squamous Carcinoma
- ClinicalTrials.gov ID
- NCT00642239
- Acronym / sponsor ID
- CMNa-ESO-01-2007
- Conditions
- Esophageal Carcinoma
- Keywords
- Sodium Glycididazole, Radiochemotherapy, Esophageal Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shandong Luye Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 25 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: placeboConcurrent radiochemotherapy and placebo |
| 1 | Experimental | Drug: Sodium Glycididazoleconcurrent radiochemotherapy and Sodium Glycididazole |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placeboplacebo in 100 mL 0.9% NaCl intravenous drip in 30 minutes,then begin radiotherapy in 60 minutes.duration of treatment is 6 weeks. | Drug | 2 |
| Sodium GlycididazoleAlso: CMNaSodium 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. | Drug | 1 |
Primary outcome
tumour local control rate
Time frame: 6 weeks
1 secondary outcome
survival rate
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lvhua Wang, Doctor principal investigator
Cancer Hospital Chinese Academy of Medical Science
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Glycididazole in people with Esophageal Carcinoma, run by Shandong Luye Pharmaceutical Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lvhua Wang, Doctor (86-10-87788503, wlhwq@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumour local control rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2008.