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Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors (HETERERO)

Primary Purpose

Recurrent Cancer, Prostate Cancer, Cervical Cancer

Status

Recruiting

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

loco-regional hyperthermia

About this trial

This is an interventional treatment trial for Recurrent Cancer focused on measuring re-irradiation, hyperthermia, local recurrence, hyperthermic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

prior radiotherapy of the treatment side with a treatment dose > 30 Gray (Gy) EQD2 (calculated with alpha/beta value of 9)
local/ regional / or oligometastatic tumor recurrence. Maximum number of three macroscopic tumor lesions with at least one of them receiving prior radiotherapy
macroscopic tumor recurrence
side of recurrence is amenable to hyperthermia (abdomen, pelvis, extremities, spine, cervical lymphnodes)
planned re-irradiation dose of at least 40 Gy EQD2 (calculated with alpha/beta value of 9)

Exclusion Criteria:

>3 macroscopic tumor lesion
brain metastases
recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy)
recurrence region is not amenable to hyperthermia (lung, liver, mediastinum)
contraindications for hyperthermia (serious cariovascular disease, ICD or larger implants at the treatment site)
psychiatric disorders that impede proper informed consent
serious comorbidities with very limited prognosis quo ad vitam

Sites / Locations

Klinik für Radioonkologie und StrahlentherapieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hyperthermia

Arm Description

Patients will receive 6-8 treatments additional loco-regional hyperthermia concurrent to re-irradiation. Hyperthermia will start on the third day of fractionated radiotherapy and will be given twice per week. According to site of recurrent disease either deep-regional, capacitive or superficial hyperthermia devices may be used.

Outcomes

Primary Outcome Measures

Local tumor recurrence

Local tumor recurrence of re-irradiated lesions, calculated with the Kaplan-Meier estimates. Local recurrence after hyperthermic re-irradiation will be compared to time-to recurrence after initial treatment.

Secondary Outcome Measures

Overall survival

Overall survival after start of re-irradiation

Progression-free survival

Progression-free survival after start of re-irradiation

Freedom from distant metastases

Freedom from distant metastases after start of re-irradiation

Patient reported quality of Life

patient reported quality of life measured by the EORTC qlq-c30 questionnaire.

Full Information

NCT ID

NCT04889742

First Posted

May 12, 2021

Last Updated

May 12, 2021

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT04889742

Brief Title

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Acronym

HETERERO

Official Title

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Recruiting

Study Start Date

May 10, 2021 (Actual)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.

Detailed Description

patients that present a relapse within the previously irradiated volume can be included in this trial. These patients will receive re-irradiation according to clinical guidelines and hyperthermia as study intervention. According to tumor location hyperthermia can either be performed by microwave or by capacitive devices. The primary endpoint of this study is non-inferiority of re-irradiation compared to the initial course of radiotherapy (calculated as time to local failure).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Recurrent Cancer, Prostate Cancer, Cervical Cancer, Anal Cancer, Sarcoma, Rectal Cancer, Neuroendocrine Tumors, Esophageal Cancer, Pancreas Cancer, Squamous Cell Carcinoma

Keywords

re-irradiation, hyperthermia, local recurrence, hyperthermic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Patients will receive additional hyperthermia according to physicians´choice as a radiosensitizer to standard of care re-irradiation or re-chemoradiation.

Masking

None (Open Label)

Allocation

N/A

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hyperthermia

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

loco-regional hyperthermia

Intervention Description

loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.

Primary Outcome Measure Information:

Title

Local tumor recurrence

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

Overall survival after start of re-irradiation

Time Frame

3 years

Title

Progression-free survival

Description

Progression-free survival after start of re-irradiation

Time Frame

3 years

Title

Freedom from distant metastases

Description

Freedom from distant metastases after start of re-irradiation

Time Frame

3 years

Title

Patient reported quality of Life

Description

patient reported quality of life measured by the EORTC qlq-c30 questionnaire.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: prior radiotherapy of the treatment side with a treatment dose > 30 Gray (Gy) EQD2 (calculated with alpha/beta value of 9) local/ regional / or oligometastatic tumor recurrence. Maximum number of three macroscopic tumor lesions with at least one of them receiving prior radiotherapy macroscopic tumor recurrence side of recurrence is amenable to hyperthermia (abdomen, pelvis, extremities, spine, cervical lymphnodes) planned re-irradiation dose of at least 40 Gy EQD2 (calculated with alpha/beta value of 9) Exclusion Criteria: >3 macroscopic tumor lesion brain metastases recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy) recurrence region is not amenable to hyperthermia (lung, liver, mediastinum) contraindications for hyperthermia (serious cariovascular disease, ICD or larger implants at the treatment site) psychiatric disorders that impede proper informed consent serious comorbidities with very limited prognosis quo ad vitam

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sebastian Zschaeck, MD

Phone

+4930450650764

sebastian.zschaeck@charite.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sebastian Zschaeck, MD

Organizational Affiliation

Charité

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für Radioonkologie und Strahlentherapie

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sebastian Zschaeck, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

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