Preoperative SRS/SRT vs Postoperative SRS/SRT for Brain Metastases

NCT04422639 | Terminated Results FDA Device

• 1 other identifier: 260505
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study is a randomized, open-label, 2-arm active-controlled phase II clinical trial conducted at a single study site (UAMS). Subjects will be randomized to one of the 2 treatment arms and stratified by size of index lesion and number of brain metastases. The investigators will prospectively compare preoperative (neoadjuvant) SRS/SRT to postoperative (adjuvant) SRS/SRT in patients undergoing surgical resection for brain metastases. The investigators hypothesize that neoadjuvant SRS/SRT prior to surgical resection of brain metastases will result in improved freedom from Central Nervous System (CNS) events when compared to adjuvant SRS/SRT after surgical resection.

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Central Nervous System (CNS) Composite Event (CE)

  A CNS CE will consist of one of the following three events: Local Recurrence (LR) of the treated lesions, symptomatic radiation necrosis (SRN) to the treated lesions, or development of leptomeningeal disease (LMD).

  From date of randomization to the date of a documented LR, SRN, or LMD, whichever comes first, assessed up to 18 months.

Study Arms (2)

Arm I (pre-operative SRS/SRT)

EXPERIMENTAL

Patients undergo SRS or SRT within 15 days of randomization followed by surgery within 15 days of radiation completion. Patients may undergo additional SRS or SRT if disease returns after treatment.

Radiation: SRS/SRT

Arm II (post-operative SRS/SRT)

ACTIVE COMPARATOR

Patients undergo surgery within 15 days of randomization followed by standard-of-care SRS or SRT within 30 days of surgery. Patients may undergo additional SRS or SRT if disease returns after treatment.

Radiation: SRS/SRT

Interventions

SRS/SRT RADIATION

Comparing pre-operative SRS/SRT to post-operative SRS/SRT

Arm I (pre-operative SRS/SRT); Arm II (post-operative SRS/SRT)

Eligibility Criteria

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

You may qualify if:

• Patients with prior histopathological diagnosis of cancer other than small cell lung cancer, lymphoma, and germ cell histologies.
• MR imaging of the brain with findings strongly suggestive of metastatic tumor(s) as assessed by the radiologist.
• Seen by a neurosurgeon or radiation oncologist and judged to be appropriate for participation in this study, including the ability to tolerate both surgery and SRS/SRT, e.g., the ability to lie flat in a stereotactic soft head frame.
• ECOG ≤ 2
• index lesion(s) appropriate for resection, not previously treated with SRS/SRT.
• Index lesion(s) should be \> 2 cm and \< 5 cm in largest dimension, and require resection. Alternatively, patients with a diagnosis of melanoma and a lesion \< 1.5cm in largest dimension may also be included. o All other brain lesions must be appropriate for SRS/SRT alone and treated according to physician preference. Prior neurosurgery and/or prior SRS/SRT at a non-overlapping location are permitted at the discretion of the treating physician.
• \- MRI confirmed 1-10 lesions, 1-2 of which are the index lesions undergoing surgery.
• Each non-index lesion (up to 10) must measure ≤ 3.0 cm in maximal extent on contrasted MRI scan, and not otherwise require resection.
• Clinical indication and plan for stereotactic radiosurgery to all known brain lesions requiring treatment (≤ 10 metastases).
• Surgical resection able to be performed within 15 days of radiotherapy completion.
• Written informed consent obtained from subject, or a legally designated power of attorney and ability for subject to comply with the requirements of the study.
• Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of radiation. WOCBP is a female patient less than 50 years of age or who has menstruated within the last 12 months.
• Platelet count \> 80 k/cumm, Hgb \> 7.5 gm/dL, INR \< 1.3, ANC \> 1.5 k/cumm

You may not qualify if:

• Not a surgical candidate per neurosurgeon's discretion.
• Contraindication to general anesthesia.
• Not a radiosurgical candidate per radiation oncologist's discretion.
• Metastatic germ cell tumor, small cell carcinoma, leukemia, multiple myeloma or lymphoma or any primary brain tumor
• ECOG \> 2
• \< 3 months expected survival
• Radiologic documentation of hydrocephalus in addition to symptoms of hydrocephalus
• Radiographic or cytologic evidence of leptomeningeal disease.
• Imaging Findings:
• Midline shift \> 6mm
• \>10 lesions, one of which is the index lesion
• Largest lesion \> 5cm
• Pregnancy
• Known allergy to gadolinium, pacemaker, or other contraindication such as metal implant that is not safe for MRI. Patients with MRI-compatible implants are eligible.
• Patients who have local recurrence of previously treated brain metastasis.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72223, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Outcome measures not computed because study closed prior to completion of follow-up visits so there is nothing to analyze.

Results Point of Contact

• Title: Assistant Director of Cancer Clinical Trials
• Organization: University of Arkansas for Medical Sciences

bscanlan@uams.edu

501-686-8274

Study Officials

• Analiz Rodriguez, MD, PhD

  UAMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 9, 2020
• Study Start: August 24, 2020
• Primary Completion: March 27, 2023
• Study Completion: March 27, 2023
• Last Updated: July 28, 2023
• Results First Posted: July 28, 2023

Record last verified: 2023-07

Locations

US (1)