Trials / Unknown
UnknownNCT02603159
Different Cycles of Capecitabine Usage in Esophageal Cancer Concurrent Chemoradiotherapy
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- The First Affiliated Hospital of Henan University of Science and Technology · Academic / Other
- Sex
- All
- Age
- 45 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Definitive chemoradiotherapy with cisplatin with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer.But in China because of its toxic reaction, most of patients stop the halfway.Because low toxicity, Capecitabine is widely used in the chemotherapy of esophageal cancer. The purpose of this experiment was to study the different cycle on capecitabine with chemotherapy for esophageal cancer chemoradiation effect.We are prepared to within 2 years study recruited 200 patients with esophageal cancer.The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate,pathologic complete response rate and adverse events.
Detailed description
We recruited the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The the patients was divided into two groups. Group 1: Capecitabine + chemoradiation, radiation at the end of the stop using capecitabine. Group 2: Capecitabine + chemoradiation, at the end of the radiotherapy with capecitabine consolidating treatment for 5 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Capecitabine(Aibin) | Capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total |
| RADIATION | radiotherapy | Concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2017-12-01
- Completion
- 2019-12-01
- First posted
- 2015-11-11
- Last updated
- 2015-11-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02603159. Inclusion in this directory is not an endorsement.