Trials / Terminated
TerminatedNCT02721550
A Trial of CMNa Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced ESCC
A Perspective Trial of Sodium Glycididazole Combined With Preoperatie Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- Shandong Cancer Hospital and Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a perspective, multicenter,single arm, open label study to evaluate the efficacy and safety of treatment with CMNa combined with preoperatie concurrent chemoradiotherapy in patients with locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (pathologic Complete Response) will be done as defined in the protocol.
Detailed description
The primary end ponit of this study is pathological complete response.And the primary hypothesis is the CMNa will improve patholofical response rate and thus improve OS、DFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is 40 cases.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sodium Glycididazole | 800mg/m2，dissolved in 100ml physiological saline(Now with chef),ivgtt,finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy, total 4 weeks course. |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2018-06-30
- Completion
- 2018-06-30
- First posted
- 2016-03-29
- Last updated
- 2019-10-11
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02721550. Inclusion in this directory is not an endorsement.