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NCT Number: NCT03238378

Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

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.

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Key information

Conditions

Locally Recurrent Head and Neck Cancer Body Temperature Changes Head and Neck Neoplasms Heat Stress Disorders Hyperthermia Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Radiation Therapy, University Hospital Erlangen

Erlangen, 91054, Germany

Location status: Recruiting

Location contact

Vratislav Strnad, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brachytherapy

Radiation

Brachytherapy d 1-5(6)

Hyperthermia

Other

Hyperthermia d 2 + 5

Primary outcomes

  1. Late side effects

    Time frame: Effects are followed up to 5 years after therapy

    Comparison late side effects to standard therapy

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Vratislav Strnad, MD

CONTACT

[email protected]

++49 9131 85 ext. 33968

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study title

SALVAGE BRACHYTHERAPY WITH INTERSTITIAL HYPERTHERMIA FOR LOCALLY RECURRENT HEAD & NECK CARCINOMA FOLLOWING PREVIOUSLY EXTERNAL BEAM RADIATION THERAPY: A PROSPECTIVE PHASE II STUDY

Acronym: HyBT-H&N

Important dates

Study start
2017
Primary completion
2022
Study completion
2027
First posted
Aug 3, 2017
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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