Salvage Brachytherapy and Hyperthermia for Recurrent H&N-... | NCT03238378

Studies
Salvage Brachytherapy and Hyperthermia for Recurrent H&N-tumours

NCT03238378

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Recruiting

Last Update Posted

Jun 8, 2018Actual

Enrollment

96Estimated

Phase

Not Applicable

Conditions

Locally Recurrent Head and Neck Cancer

Interventions

Brachytherapy
Hyperthermia

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2017Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jul 31, 2017

First Submission Date that Met QC Criteria

Jul 31, 2017

First Posted Date

Aug 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2018

Last Update Posted Date

Jun 8, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vratislav Strnad, Head of the Interstitial Brachytherapy at the Dept. of Radiooncology, University of Erlangen-Nürnberg Medical SchoolPrincipal Investigator

Lead Sponsor

University of Erlangen-Nürnberg Medical SchoolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Therapy	Experimental	Brachytherapy d1-5(6) Hyperthermia d2 + 5	Radiation: Brachytherapy Other: Hyperthermia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brachytherapy	Radiation	Brachytherapy d 1-5(6)	Therapy
Hyperthermia

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vratislav Strnad, MD	Contact	++49 9131 85	33968	vratislav.strnad@uk-erlangen.de

Overall Officials

Name	Affiliation	Role
Vratislav Strnad, MD	Dept. of Radiation Therapy, University Hospital Erlangen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Radiation Therapy, University Hospital Erlangen	Recruiting	Erlangen		91054	Germany

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms
D000084462	Hyperthermia

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001832	Body Temperature Changes
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001918	Brachytherapy
D003972	Diathermy

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D006979	Hyperthermia, Induced

Browse Leaves

Not provided

Browse Branches

Not provided