Back to resultsSalvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours (HyBT-H&N)
Primary Purpose
Locally Recurrent Head and Neck Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Brachytherapy
Hyperthermia
Sponsored by
About this trial
This is an interventional treatment trial for Locally Recurrent Head and Neck Cancer focused on measuring head and neck cancer, Locally recurrent head and neck cancer, Brachytherapy, Hyperthermia
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed recurrent carcinoma of the head and neck region
- Stage rcT1-3
- Tumor anatomy and location suitable for brachytherapy techniques.
- cN0/pN0 or rpN+ & R0 with <3 pos. LND & without invasion of capsula.
- M0
- ECOG 0-2
- Previous radiation therapy up to at least 50 Gy
- Previous radiation therapy completed more than 6 months ago
- Written study-specific informed consent
Exclusion Criteria:
- cT4
- rpN+ with >2 pos. LND or invasion of capsula
- Pregnant or lactating women
- Collagen vascular disease
- The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar
- Psychiatric disorders
Sites / Locations
- Dept. of Radiation Therapy, University Hospital ErlangenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Therapy
Arm Description
Brachytherapy d1-5(6) Hyperthermia d2 + 5
Outcomes
Primary Outcome Measures
Late side effects
Comparison late side effects to standard therapy
Secondary Outcome Measures
Quality of life
Assessment of quality of life with EORTC questionnaires
Rate of local recurrencies
Assessment of cumulative local recurrence rate
Overall survival
Rate of Overall survival
Full Information
NCT ID
NCT03238378
First Posted
July 31, 2017
Last Updated
June 6, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03238378
Brief Title
Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
Acronym
HyBT-H&N
Official Title
SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the present trial is to assess the prospective results of protocol-based interstitial pulsed-dose-rate (PDR) brachytherapy with interstitial hyperthermia (iHT) in a group of selected patients where salvage surgery with clear resection margins was not possible.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Recurrent Head and Neck Cancer
Keywords
head and neck cancer, Locally recurrent head and neck cancer, Brachytherapy, Hyperthermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Therapy
Arm Type
Experimental
Arm Description
Brachytherapy d1-5(6) Hyperthermia d2 + 5
Intervention Type
Radiation
Intervention Name(s)
Brachytherapy
Intervention Description
Brachytherapy d 1-5(6)
Intervention Type
Other
Intervention Name(s)
Hyperthermia
Intervention Description
Hyperthermia d 2 + 5
Primary Outcome Measure Information:
Title
Late side effects
Description
Comparison late side effects to standard therapy
Time Frame
Effects are followed up to 5 years after therapy
Secondary Outcome Measure Information:
Title
Quality of life
Description
Assessment of quality of life with EORTC questionnaires
Time Frame
up to 5 years after therapy
Title
Rate of local recurrencies
Description
Assessment of cumulative local recurrence rate
Time Frame
up to 5 years after therapy
Title
Overall survival
Description
Rate of Overall survival
Time Frame
up to 5 years after therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed recurrent carcinoma of the head and neck region
Stage rcT1-3
Tumor anatomy and location suitable for brachytherapy techniques.
cN0/pN0 or rpN+ & R0 with <3 pos. LND & without invasion of capsula.
M0
ECOG 0-2
Previous radiation therapy up to at least 50 Gy
Previous radiation therapy completed more than 6 months ago
Written study-specific informed consent
Exclusion Criteria:
cT4
rpN+ with >2 pos. LND or invasion of capsula
Pregnant or lactating women
Collagen vascular disease
The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar
Psychiatric disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vratislav Strnad, MD
Phone
++49 9131 85
Ext
33968
Email
vratislav.strnad@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vratislav Strnad, MD
Organizational Affiliation
Dept. of Radiation Therapy, University Hospital Erlangen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Radiation Therapy, University Hospital Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vratislav Strnad, MD
Email
vratislav.strnad@uk-erlangen.de
12. IPD Sharing Statement
Learn more about this trial
Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
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