Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Locally Recurrent Head and Neck Cancer Radiation: Brachytherapy Other: Hyperthermia Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY
Actual Study Start Date : March 29, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Therapy
Brachytherapy d1-5(6) Hyperthermia d2 + 5
Radiation: Brachytherapy
Brachytherapy d 1-5(6)

Other: Hyperthermia
Hyperthermia d 2 + 5




Primary Outcome Measures :
  1. Late side effects [ Time Frame: Effects are followed up to 5 years after therapy ]
    Comparison late side effects to standard therapy


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: up to 5 years after therapy ]
    Assessment of quality of life with EORTC questionnaires

  2. Rate of local recurrencies [ Time Frame: up to 5 years after therapy ]
    Assessment of cumulative local recurrence rate

  3. Overall survival [ Time Frame: up to 5 years after therapy ]
    Rate of Overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03238378


Contacts
Layout table for location contacts
Contact: Vratislav Strnad, MD ++49 9131 85 ext 33968 vratislav.strnad@uk-erlangen.de

Locations
Layout table for location information
Germany
Dept. of Radiation Therapy, University Hospital Erlangen Recruiting
Erlangen, Germany, 91054
Contact: Vratislav Strnad, MD       vratislav.strnad@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Layout table for investigator information
Principal Investigator: Vratislav Strnad, MD Dept. of Radiation Therapy, University Hospital Erlangen
Layout table for additonal information
Responsible Party: Vratislav Strnad, Head of the Interstitial Brachytherapy at the Dept. of Radiooncology, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03238378    
Other Study ID Numbers: HyBT-H&N
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vratislav Strnad, University of Erlangen-Nürnberg Medical School:
head and neck cancer
Locally recurrent head and neck cancer
Brachytherapy
Hyperthermia
Additional relevant MeSH terms:
Layout table for MeSH terms
Head and Neck Neoplasms
Hyperthermia
Fever
Neoplasms by Site
Neoplasms
Body Temperature Changes
Heat Stress Disorders
Wounds and Injuries