Surgery and Radiation vs. Radiation Alone for Brain Cancer
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?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either pre-operative or post-operative stereotactic radiosurgery and surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Brain Surgery
- Stereotactic Radiosurgery
Brain Surgery is already approved in European Union, United States, Canada, Japan for the following indications:
- Brain metastases
- Primary brain tumors
- Vascular malformations
- Brain metastases
- Primary brain tumors
- Epilepsy
- Trigeminal neuralgia
- Brain metastases
- Primary brain tumors
- Vascular malformations
- Brain metastases
- Primary brain tumors
- Epilepsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
National Cancer Institute (NCI)
Collaborator