Evaluation of Repeated Whole Brain Radiotherapy Versus Best Supportive Care for Multiple Brain Metastases.

NCT03288272 | Unknown Phase 2

• 1 other identifier: ERASER
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Whole Brain Radiotherapy (WBRT) has been established as the treatment standard in patients with multiple cerebral metastases from solid tumors. However, intracerebral recurrence is possible and a repeated WBRT may be indicated to improve intracerebral tumor control. Each institutsion offers different dosing regimens, which have all been published to be safe and effective. Some favor best supportive care only. The current study protocol is aimed at evaluating primarily the toxicity as well as secondarily the local and loco-regional tumor control, overall survival and QoL after repeated WBRT using 2 different dose concepts (20 Gy in 10 Fx vs. 30 Gy in 15 Fx) compared to BSC.

Conditions

Brain Metastasases

Outcome Measures

Primary Outcomes (1)

• Toxicity

  The primary endpoint is toxicity according to CTCAE after whole brain radiotherapy.

  3 months

Secondary Outcomes (3)

• loco-regional progression-free survival

  6 months

• Quality of Life (QOL)

  6 months

• Survival

  6 months

Study Arms (3)

Arm 1 - WBRT 10 x 2 Gy

ACTIVE COMPARATOR

Arm 1 - WBRT 10 x 2 Gy Whole brain radiotherapy with a total dose of 20 Gy in single fractions of 2 Gy

Radiation: Whole Brain Radiotherapy

Arm 2 - WBRT 15 x 2 Gy

ACTIVE COMPARATOR

Arm 2 - WBRT 15 x 2 Gy Whole brain radiotherapy with a total dose of 30 Gy in single fractions of 2 Gy

Radiation: Whole Brain Radiotherapy

Arm 3 - Best Supportive Care

ACTIVE COMPARATOR

Symptomatic treatment includes steroids, pain medication, nutritional support etc.

Other: Best Supportive Care

Interventions

Whole Brain Radiotherapy RADIATION

Radiotherapy of the whole brain

Arm 1 - WBRT 10 x 2 Gy; Arm 2 - WBRT 15 x 2 Gy

Best Supportive Care OTHER

Best Supportive Care including nutrition, pain medication, steroids as needed

Arm 3 - Best Supportive Care

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
• MR-imaging confirmed cerebral metastases (\>1)
• age ≥ 18 years of age
• Karnofsky Performance Score ³60
• 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 of the patients to take part in the study
• Patients who have not yet recovered from acute high-grade toxicities of prior therapies
• Pregnant or lactating women
• Participation in another clinical study or observation period of competing trials, respectively

Sponsors & Collaborators

• Stephanie Combs: lead

Study Sites (1)

Technische Universität München (TUM), Klinikum rechts der Isar

Munich, 81675, Germany

RECRUITING

Related Publications (1)

• Scharp M, Hauswald H, Bischof M, Debus J, Combs SE. Re-irradiation in the treatment of patients with cerebral metastases of solid tumors: retrospective analysis. Radiat Oncol. 2014 Jan 3;9:4. doi: 10.1186/1748-717X-9-4.

  PMID: 24387239 RESULT

Study Officials

• Stephanie E Combs, Prof. Dr.

  Professor and Department Chair

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie E Combs, Prof. Dr.

CONTACT

+49-89-4140-; stephanie.combs@tum.de

Carmen Kessel, MA

CONTACT

+49-89-4140-; carmen.kessel@tum.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chair

Model Details: Randomization Best Supportive Care, Two Radiotherapy Dosing Regimens

Study Record Dates

• First Submitted: May 15, 2016
• First Posted: September 20, 2017
• Study Start: April 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)