Radiation Dose Study of Concurrent Chemoradiotherapy With Cisplatin Plus Fluorouracil in Oesophageal Cancer
NCT01646853 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500
Last updated 2012-07-20
Summary
The objective of this study is to determine the optimal radiation dosage used in concurrent chemo-radiotherapy in Chinese population. A dose climbing experiment is carried out with an initiate dose of 50Gy conventionally applied in Western countries.
Conditions
- Esophageal Neoplasms
Interventions
- RADIATION
-
Megavoltage photon beam
initial dose:50Gy/2Gy/25f,5days/week escalation dose:4Gy/2Gy/2f
- DRUG
-
cisplatin-fluorouracil chemotherapy
cisplatin 75 mg/m2 on day 1 with standard hydration fluorouracil 1000 mg/m2/day1 i.v. by continuous infusion from day 1 to day 4 of each cycle
Sponsors & Collaborators
-
Simcere Pharmaceutical Co., Ltd
lead OTHER
Principal Investigators
-
Xinchen Sun, M.D.,Ph.D. · The First Affiliated Hospital with Nanjing Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-08-31
- Primary Completion
- 2013-12-31
Countries
- China
Study Locations
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