Supportive Care With or Without Repeated Whole Brain Radiotherapy in Patients With Recurrent Brain Metastases

NCT04084431 | Withdrawn

• 1 other identifier: RECARE Trial Version 1.1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with solid cancers may develop cerebral metastases, requiring whole brain radiotherapy (WBRT). Furthermore, in several cases, a secondary course of WBRT might be required due to intracerebral recurrence and limited options for alternative treatments, besides optimal supportive care (OSC). There have been few reports on re-irradiation of the whole brain, but further evaluation especially of the optimal dose concept is warranted. Especially, the efficacy compared to OSC has to date not been evaluated. The present trial aims at evaluating the efficacy of a repeated WBRT with a total dose of 20 Gy in 10 fractions compared to OSC. Primary endpoint is time to WHO performance status (PS) deterioration to more than 3 (duration of functional independence). Secondary endpoints are quality of life, overall survival, radiation-induced toxicity and functional independence assessed by the Barthel Index of Activities of Daily Living (ADL)1.

Conditions

Brain Metastases

Keywords

repeated whole brain radiation therapy

Outcome Measures

Primary Outcomes (1)

• Time to WHO PS to more than 3

  WHO Performance status

  up to 4 years or from date of randomization unitl the date of documented date of death from any cause

Secondary Outcomes (1)

• OS

  up to 4 years or from date of randomization unitl the date of documented date of death from any cause

Study Arms (2)

WBRT (10 x 2 Gy) + OSC

ACTIVE COMPARATOR

Whole brain radiotherapy will be applied with a total dose of 20 Gy in 10 fractions (single dose of 2 Gy). OSC as needed.

Radiation: Radiation

Optimal Supportive Care (OSC) alone

EXPERIMENTAL

Symptomatic treatment including steroids, pain medication, nutritional support, etc

Other: OSC

Interventions

Radiation RADIATION

WBRT will be applied in 10 fractions with single doses of 2 Gy (Arm 1) to the whole brain

WBRT (10 x 2 Gy) + OSC

OSC OTHER

optimal supportive Care (OSC) alone

Optimal Supportive Care (OSC) alone

Eligibility Criteria

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

You may qualify if:

• histologically confirmed malignancy
• previous WBRT or prophylactic whole brain irradiation (PCI)
• MR- or CT-imaging confirmed recurrent cerebral metastases (\>10)
• Or: MR- or CT-imaging confirmed recurrent cerebral metastases (1-10) and inability to perform SRS or surgery (e.g. meningeal carcinomatosis), concluded by interdisciplinary conference
• age ≥ 18 years
• Time between initial WBRT/PCI and recurrent WBRT \>3 months
• WHO performance score ≤3
• For women with childbearing potential, (and men) adequate contraception.
• Ability of subject to understand character and individual consequences of the clinical trial
• Written informed consent (must be available before enrolment in the trial)

You may not qualify if:

• refusal to take part in the study
• Pregnant or lactating women
• Participation in another competing clinical study or observation period of competing trials, respectively
• Ability to perform SRS or surgery on brain metastases as a treatment alternative
• Systemic anticancer treatment \<4 weeks for chemotherapy and \<1 week for TKIs and targeted therapies before randomisation.
• Persons who are in a relationship of dependence/employment with the investigators
• Cerebral lymphomas, metastases of germ cell tumours

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, randomized 2-armed Phase II Pilot-Trial

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: September 10, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)