NCT05438212 is a Phase 3 clinical trial of Brain Surgery in Metastatic Malignant Neoplasm in the Brain, sponsored by NRG Oncology.

Who is sponsoring NCT05438212?

NCT05438212 is sponsored by NRG Oncology.

What drugs are being tested in NCT05438212?

Interventions in NCT05438212: Brain Surgery, Quality-of-Life Assessment, Questionnaire Administration, Stereotactic Radiosurgery.

What condition does NCT05438212 study?

NCT05438212 studies Metastatic Malignant Neoplasm in the Brain.

Is NCT05438212 still recruiting?

NCT05438212 is currently active, enrolled. Last updated 3 April 2026.

Last reviewed 2026-04-03 · How we verify

NCT05438212

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparing the Addition of Radiation Either Before or After Surgery for Patients With Brain Metastases

Active, enrolled Phase 3 Last updated 3 April 2026

What this trial tests

Phase 3 trial testing Brain Surgery in Metastatic Malignant Neoplasm in the Brain in 237 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

24 October 2022

Primary endpoint
16 March 2027

16 March 2027

Quick facts

Lead sponsor	NRG Oncology
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	237
Start date	24 October 2022
Primary completion	16 March 2027
Estimated completion	16 March 2027
Sites	216 locations across Japan, Canada, United States

Drugs / interventions tested

Brain Surgery
Quality-of-Life Assessment
Questionnaire Administration
Stereotactic Radiosurgery

Conditions studied

Metastatic Malignant Neoplasm in the Brain — all drugs for Metastatic Malignant Neoplasm in the Brain →

Sponsor

NRG Oncology — full company profile →

Who can join

18 and older, any sex, with Metastatic Malignant Neoplasm in the Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase III trial compares the usual treatment of surgery after stereotactic radiosurgery (SRS) to receiving SRS before surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation to target tumors and minimizes effect on normal surrounding brain tissue. The combination of surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases. This study investigates whether treating with SRS before surgery may be better than SRS after surgery in reducing the possibility of the tumor coming back, reducing or preventing the cancer from spreading to other areas of the brain and reducing the risk of scarring on the brain from radiation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The dilemma of radiation necrosis from diagnosis to treatment in the management of brain metastases.
Mayo ZS, Billena C, Suh JH, Lo SS, et al · · 2024 · cited 34× · PMID 38437665 · DOI 10.1093/neuonc/noad188
Response of treatment-naive brain metastases to stereotactic radiosurgery.
Ene CI, Abi Faraj C, Beckham TH, Weinberg JS, et al · · 2024 · cited 20× · PMID 38697991 · DOI 10.1038/s41467-024-47998-8
Risk Factors for Progression and Toxic Effects After Preoperative Stereotactic Radiosurgery for Patients With Resected Brain Metastases.
Prabhu RS, Akinyelu T, Vaslow ZK, Matsui JK, et al · · 2023 · cited 20× · PMID 37289451 · DOI 10.1001/jamaoncol.2023.1629
Novel Mechanisms and Future Opportunities for the Management of Radiation Necrosis in Patients Treated for Brain Metastases in the Era of Immunotherapy.
Vaios EJ, Winter SF, Shih HA, Dietrich J, et al · · 2023 · cited 18× · PMID 37173897 · DOI 10.3390/cancers15092432
Single-Fraction Versus Fractionated Preoperative Radiosurgery for Resected Brain Metastases: A PROPS-BM International Multicenter Cohort Study.
Prabhu RS, Akinyelu T, Vaslow ZK, Matsui JK, et al · · 2024 · cited 14× · PMID 37717787 · DOI 10.1016/j.ijrobp.2023.09.012
Modern Stereotactic Radiotherapy for Brain Metastases from Lung Cancer: Current Trends and Future Perspectives Based on Integrated Translational Approaches.
Levis M, Gastino A, De Giorgi G, Mantovani C, et al · · 2023 · cited 11× · PMID 37760591 · DOI 10.3390/cancers15184622
Preoperative radiosurgery for brain metastases (PREOP-1): A feasibility trial.
Rogers S, Schwyzer L, Lomax N, Alonso S, et al · · 2024 · cited 8× · PMID 38938931 · DOI 10.1016/j.ctro.2024.100798
Preoperative stereotactic radiosurgery in the management of brain metastases and gliomas.
Lehrer EJ, Kowalchuk RO, Ruiz-Garcia H, Merrell KW, et al · · 2022 · cited 8× · PMID 36353610 · DOI 10.3389/fsurg.2022.972727

Verify or expand the search:

Other trials of Brain Surgery

Trials testing the same drug.

NCT06650163 — Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tu · Phase 1 · recruiting
NCT04474925 — Pre- Versus Post-operative SRS for Resectable Brain Metastases · Phase 3 · terminated
NCT04810871 — Surgical Resection of Latent Brain Tumors Prior to Recurrence · NA · suspended

Other recruiting trials for Metastatic Malignant Neoplasm in the Brain

Currently open trials in the same condition.

NCT07339085 — Advanced Magnetic Resonance Imaging for the Identification of Recurrent Brain Tumors and Radiation Necrosis · NA · recruiting
NCT06500455 — Testing Longer Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients With Cancer That Has Spread to · Phase 3 · recruiting
NCT06650163 — Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tu · Phase 1 · recruiting
NCT06328686 — Arginine and Whole Brain Radiation Therapy for the Treatment of Patients With Brain Metastases · EARLY_PHASE1 · recruiting
NCT05588453 — Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to · Phase 1, PHASE2 · recruiting

Other NRG Oncology trials

Trials by the same sponsor.

NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive · Phase 3 · not yet recruiting
NCT07452458 — Temporally-Modulated Pulsed Radiation Therapy Versus Standard Radiation Therapy for the Treatment of Newly Diagnosed, ID · Phase 3 · not yet recruiting
NCT07166406 — Testing Immunotherapy With or Without Stereotactic Body Radiation Therapy in Patients With Advanced Liver Cancer, HELIO- · Phase 3 · recruiting
NCT07097142 — Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemothera · Phase 3 · recruiting
NCT06958328 — Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05438212 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NRG Oncology
Last refreshed: 3 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05438212.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing