NCT03238378

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Mar 2017Dec 2027

Study Start

First participant enrolled

March 29, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

June 8, 2018

Status Verified

June 1, 2018

Enrollment Period

5.8 years

First QC Date

July 31, 2017

Last Update Submit

June 6, 2018

Conditions

Locally Recurrent Head and Neck Cancer

Keywords

head and neck cancerLocally recurrent head and neck cancerBrachytherapyHyperthermia

Outcome Measures

Primary Outcomes (1)

  • Late side effects

    Comparison late side effects to standard therapy

    Effects are followed up to 5 years after therapy

Secondary Outcomes (3)

  • Quality of life

    up to 5 years after therapy

  • Rate of local recurrencies

    up to 5 years after therapy

  • Overall survival

    up to 5 years after therapy

Study Arms (1)

Therapy

EXPERIMENTAL

Brachytherapy d1-5(6) Hyperthermia d2 + 5

Radiation: BrachytherapyOther: Hyperthermia

Interventions

BrachytherapyRADIATION

Brachytherapy d 1-5(6)

Therapy
HyperthermiaOTHER

Hyperthermia d 2 + 5

Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Radiation Therapy, University Hospital Erlangen

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Head and Neck NeoplasmsHyperthermia

Interventions

BrachytherapyDiathermy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsHyperthermia, Induced

Study Officials

  • Vratislav Strnad, MD

    Dept. of Radiation Therapy, University Hospital Erlangen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vratislav Strnad, MD

CONTACT

++49 9131 85vratislav.strnad@uk-erlangen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Interstitial Brachytherapy at the Dept. of Radiooncology

Study Record Dates

First Submitted

July 31, 2017

First Posted

August 3, 2017

Study Start

March 29, 2017

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2027

Last Updated

June 8, 2018

Record last verified: 2018-06

Locations

DE(1)