Re-TREAT: Re-irradiation for Relapsed Brain Metastases

NCT05126875 | Unknown

• 1 other identifier: RE-TREAT
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The Re-TREAT study is a prospective clinical, phase 2, interventional, single-arm, multicenter trial for patients with local relapse of one or more brain metastases. Patients with recurrence of one or more brain metastases that have previously been treated with stereotactic radiosurgey (SRS) are treated with repeated SRS. The aim is to evaluate the efficacy and toxicity of salvage SRS. The primary outcome is local control of the relapsed tumor and the secondary endpoints include toxicity as evaluated by the investigator and quality of life measured as a patient reported outcome. As an exploratory endpoint, the value of advanced MRI (magnetic resonance imaging) and PET (positron emission tomography) imaging as a biomarker for prediction of response to treatment or toxicity will be studied.

Conditions

Cancer; Brain Metastases, Adult

Outcome Measures

Primary Outcomes (1)

• Freedom from progression of treated metastasis

  Freedom from progression of lesion size defined as stable or decreasing unidimensional measurement (longest diameter) on T1-weighted contrast enhanced magnetic resonance imaging (MRI)

  3 months post treatment

Secondary Outcomes (6)

• Adverse events

  12 months

• Overall response

  3 months

• Neurological status

  6 months

• Time to intracranial relapse

  From date of treatment until the day of radiologically documented relapse in the brain assessed up to 12 months

• Overall survival

  From date of treatment until date of death from any cause assessed up to 12 months

Other Outcomes (2)

• Positron emission tomography using fluoro-ethyl tyrosine (FET) tracer before and after treatment

  3 months

• Dynamic MRI using DCE (dynamic contrast enhancement) perfusion measurement before and after treatment

  3 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Treatment with stereotactic radiosurgery

Radiation: Repeated stereotactic radiosurgery

Interventions

Repeated stereotactic radiosurgery RADIATION

Repeated stereotactic radiosurgery to recurring brain metastases

Also known as: SRS

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Brain metastases of solid tumor (carcinoma of unknown origin may be included but histological verification in case of BM alone is required)
• Progression of previously treated lesion as decided by the multidisciplinary team conference
• Previous single fraction SRS in area in question and dose plans must be available electronically
• Previous single fraction SRS given \> 3 months previously
• ECOG (Eastern Cooperative Oncology Group) performance status ≤2
• Life expectancy \>3 months
• Signed written consent.
• Patients may have more than one recurring lesion and may also have new, untreated metastases which may be treated with standard SRS (up to a total of 4 metastases in accordance with Danish national guidelines).

You may not qualify if:

• Two previous courses of radiotherapy for the same metastasis (e.g. SRS and WBRT)
• Target lesions located in- or in proximity to eloquent brain areas that require reduction of radiotherapy dose
• Target lesion gross tumor volume (GTV) for radiotherapy greater than 14,1 cm3 (equivalent to a sphere with a diameter of 3 cm)
• Current or planned concomitant medical treatment that is likely to be active against brain metastases (e.g. tyrosine kinase inhibitors for EGFR-positive (epidermal growth factor receptor) non-small cell lung cancer) or that may influence interpretation of images (e.g. bevacizumab, a monoclonal antibody directed towards VEGF (vascular endothelial growth factor)) in the opinion of the investigators
• Contraindication to magnetic resonance imaging using Gadolinium contrast enhancement (e.g. pacemaker, metallic implant or impaired renal function)
• Rapid extracranial disease progression that in the opinion of the investigators confer a high risk of drop out from the study without evaluation scan at 3 months

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Søren Møller, MD, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Søren Møller, MD, PhD

CONTACT

+45 35451693; soeren.moeller.01@regionh.dk

Gitte F Persson, MD, PhD

CONTACT

+45 38689299; gitte.persson@regionh.dk

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: MD, Consultant

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: November 19, 2021
• Study Start: July 1, 2021
• Primary Completion: August 20, 2023
• Study Completion: August 20, 2023
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

DK (1)