Combination of Hyperthermia and Concurrent Chemoradiotherapy (CCRT) for Recurrent Head and Neck Cancer
NCT02567383 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2020-07-28
Summary
Clinical experience of with hyperthermia combined with radiotherapy and chemotherapy for recurrent head and neck cancer is limited. The primary goals of hyperthermia combined with CCRT on recurrent head and neck cancer are tumor response rate, while secondary goals are rates of acute and late adverse effects, local control rate, distant metastasis rate, progression-free rate and overall survival rate.
Conditions
- Recurrent Head and Neck Cancer
Interventions
- RADIATION
-
Radiation
5-Gy once a week for a subtotal of 10Gy/2fx a week to gross tumors, followed by 40Gy/20fx/4 weeks, total 50Gy/22fx/5weeks
- DEVICE
-
Hyperthermia; Thermotron RF-8
40 minutes within 2hr after irradiation
- DRUG
-
20mg/m2 per week for 6 weekly cycles before radiotherapy
- DRUG
-
Taxotere
10-12mg/m2 per week for 6 weekly cycles before radiotherapy
Sponsors & Collaborators
-
Shin Kong Wu Ho-Su Memorial Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-09-30
- Primary Completion
- 2021-03-31
- Completion
- 2021-03-31
Countries
- Taiwan
Study Locations
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