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

June 6, 2018 updated by: Vratislav Strnad, University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late side effects
Time Frame: Effects are followed up to 5 years after therapy
Comparison late side effects to standard therapy
Effects are followed up to 5 years after therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: up to 5 years after therapy
Assessment of quality of life with EORTC questionnaires
up to 5 years after therapy
Rate of local recurrencies
Time Frame: up to 5 years after therapy
Assessment of cumulative local recurrence rate
up to 5 years after therapy
Overall survival
Time Frame: up to 5 years after therapy
Rate of Overall survival
up to 5 years after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Vratislav Strnad, MD, Dept. of Radiation Therapy, University Hospital Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2017

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 3, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

June 6, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HyBT-H&N

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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