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Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours (HyBT-H&N)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03238378
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Vratislav Strnad, University of Erlangen-Nürnberg Medical School

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 3, 2017
Last Update Posted Date June 8, 2018
Actual Study Start Date  ICMJE March 29, 2017
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 31, 2017)		 Late side effects [ Time Frame: Effects are followed up to 5 years after therapy ]
Comparison late side effects to standard therapy
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2017)
  • Quality of life [ Time Frame: up to 5 years after therapy ]
    Assessment of quality of life with EORTC questionnaires
  • Rate of local recurrencies [ Time Frame: up to 5 years after therapy ]
    Assessment of cumulative local recurrence rate
  • Overall survival [ Time Frame: up to 5 years after therapy ]
    Rate of Overall survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours
Official Title  ICMJE SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Locally Recurrent Head and Neck Cancer
Intervention  ICMJE
  • Radiation: Brachytherapy
    Brachytherapy d 1-5(6)
  • Other: Hyperthermia
    Hyperthermia d 2 + 5
Study Arms  ICMJE Experimental: Therapy
Brachytherapy d1-5(6) Hyperthermia d2 + 5
Interventions:
  • Radiation: Brachytherapy
  • Other: Hyperthermia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2017)		 96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2027
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vratislav Strnad, MD ++49 9131 85 ext 33968 vratislav.strnad@uk-erlangen.de
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03238378
Other Study ID Numbers  ICMJE HyBT-H&N
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vratislav Strnad, University of Erlangen-Nürnberg Medical School
Study Sponsor  ICMJE University of Erlangen-Nürnberg Medical School
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vratislav Strnad, MD Dept. of Radiation Therapy, University Hospital Erlangen
PRS Account University of Erlangen-Nürnberg Medical School
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP