Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

Sponsor
Charite University, Berlin, Germany
Study ID
NCT04889742
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
May 17, 2021
Start date
May 10, 2024
Status verified
Dec 2023
Primary completion
Jan 31, 2026
Completion
Jan 31, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Hyperthermia
    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.

Primary Outcome Measure

Local tumor recurrence [ Time Frame: 3 years ]

Central Contacts

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