236 Participants Needed

Surgery and Radiation vs. Radiation Alone for Brain Cancer

Recruiting at 194 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that cytotoxic chemotherapy or tyrosine/multi-kinase inhibitors should not be taken within 3 days before, on the day of, or within 3 days after the completion of stereotactic radiosurgery (SRS).

What data supports the effectiveness of the treatment Surgery and Radiation vs. Radiation Alone for Brain Cancer?

Research shows that patients with a single brain metastasis who undergo surgery followed by radiation live longer, have fewer cancer recurrences in the brain, and maintain a better quality of life compared to those who receive only radiation.12345

Is surgery and radiation for brain cancer generally safe for humans?

Surgery for brain tumors, including craniotomy, can have risks such as surgical site infections and other complications, but these are generally well-studied and managed. Radiation therapy, like Stereotactic Radiosurgery (SRS), is also commonly used and considered safe, though it may have specific risks depending on the patient's condition. Overall, both treatments have been used safely in humans, but individual risks can vary based on factors like the patient's health and the complexity of the surgery.678910

How does the treatment of surgery and radiation differ from radiation alone for brain cancer?

The combination of surgery and radiation for brain cancer is unique because it often results in longer survival, fewer recurrences, and better quality of life compared to radiation alone. Surgery physically removes the tumor, which can be more effective in reducing cancer recurrence and improving outcomes when followed by radiation.1251112

Research Team

SH

Stuart H Burri

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for adults with 1-4 brain metastases, one needing surgery. Participants must have a lesion larger than 2cm but smaller than 5cm, not near the optic chiasm or in the brainstem, and be able to tolerate surgery and radiosurgery. They should agree to use contraception and not have had certain cancers or prior cranial radiotherapy.

Inclusion Criteria

I have had cancer other than in the brain diagnosed in the last 3 years.
My brain metastases are not near the optic nerve or in the brainstem.
My surgeon believes the tumor can be completely removed safely.
See 10 more

Exclusion Criteria

I am scheduled for chemotherapy or specific targeted therapy soon.
I am scheduled for surgery to remove more than one brain tumor.
My cancer is either a germ cell tumor, small cell carcinoma, or lymphoma.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either pre-operative or post-operative stereotactic radiosurgery and surgery

1-4 weeks
1 visit (in-person) for surgery and radiosurgery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years
Every 3 months for 2 years, then every 6 months for additional 2 years

Treatment Details

Interventions

  • Brain Surgery
  • Stereotactic Radiosurgery
Trial OverviewThe study compares adding stereotactic radiosurgery (high-dose radiation targeting only cancer areas) before or after surgical removal of brain tumors. It aims to see which sequence is more effective at controlling tumor growth and reducing symptoms.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (stereotactic radiosurgery, surgery)Experimental Treatment4 Interventions
Within 7 days before surgery, patients undergo stereotactic radiosurgery for 1 fraction. Patients undergo surgery per standard of care.
Group II: Arm I (surgery, stereotactic radiosurgery)Active Control4 Interventions
Patients undergo surgery per standard of care. Within 10-30 days after surgery, patients undergo stereotactic radiosurgery for 1 fraction.

Brain Surgery is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Brain Surgery for:
  • Brain metastases
  • Primary brain tumors
  • Vascular malformations
🇺🇸
Approved in United States as Brain Surgery for:
  • Brain metastases
  • Primary brain tumors
  • Epilepsy
  • Trigeminal neuralgia
🇨🇦
Approved in Canada as Brain Surgery for:
  • Brain metastases
  • Primary brain tumors
  • Vascular malformations
🇯🇵
Approved in Japan as Brain Surgery for:
  • Brain metastases
  • Primary brain tumors
  • Epilepsy

Find a Clinic Near You

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials
242
Recruited
105,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 48 patients with a single brain metastasis, those who underwent surgical resection followed by radiotherapy experienced significantly fewer recurrences of cancer in the brain (20% vs. 52%) compared to those who only received radiotherapy.
Patients who had surgery also had a longer overall survival (median 40 weeks vs. 15 weeks) and maintained functional independence for a longer period (median 38 weeks vs. 8 weeks), indicating that surgical intervention improves both survival and quality of life.
A randomized trial of surgery in the treatment of single metastases to the brain.Patchell, RA., Tibbs, PA., Walsh, JW., et al.[2022]
Combining surgery with radiation therapy is currently the most effective treatment for central nervous system tumors, highlighting the importance of a multi-faceted approach to cancer care.
The article emphasizes the role of advanced neuroimaging techniques in enhancing the success of surgical interventions for brain tumors, suggesting that improved imaging can lead to better surgical outcomes.
Neurosurgical management of brain tumors.Tatter, SB.[2012]
Surgical removal of solitary brain metastases in non-critical areas can be beneficial, especially when the diagnosis is uncertain, based on the treatment of 1895 patients in two studies.
For patients with multiple brain metastases or when surgery is not feasible, radiation therapy combined with steroids is effective, and short-course low-dose radiation can be as effective as longer, more aggressive treatments.
The influence of surgery and radiation therapy on patients with brain metastases.Hendrickson, FR., Lee, MS., Larson, M., et al.[2019]

References

A randomized trial of surgery in the treatment of single metastases to the brain. [2022]
Neurosurgical management of brain tumors. [2012]
The influence of surgery and radiation therapy on patients with brain metastases. [2019]
Surgical treatment of solitary brain metastases: Monmouth County experience. [2004]
Role of Radiosurgery in the Treatment of Brain Metastasis. [2020]
Patterns in neurosurgical adverse events: intracranial neoplasm surgery. [2012]
Surgical mortality and selected complications in 273 consecutive craniotomies for intracranial tumors in pediatric patients. [2012]
Surgical Site Infections in Glioblastoma Patients-A Retrospective Analysis. [2023]
Comorbidity Burden and Presence of Multiple Intracranial Lesions Are Associated with Adverse Events after Surgical Treatment of Patients with Brain Metastases. [2020]
10.United Statespubmed.ncbi.nlm.nih.gov
Defining a new neurosurgical complication classification: lessons learned from a monthly Morbidity and Mortality conference. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Stereotactic radiosurgery in the management of brain metastasis. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Surgery and radiotherapy compared with gamma knife radiosurgery in the treatment of solitary cerebral metastases of small diameter. [2006]