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Surgery and Radiation vs. Radiation Alone for Brain Cancer
Study Summary
This trialcompares two treatments to help stop cancer spread to the brain: surgery w/ radiation therapy or radiation therapy alone. Radiation is targeted to cancer cells while avoiding healthy brain tissue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am scheduled for chemotherapy or specific targeted therapy soon.I am scheduled for surgery to remove more than one brain tumor.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.My untreated cancer spots are smaller than 4.0 cm.My cancer is either a germ cell tumor, small cell carcinoma, or lymphoma.I have 1-4 brain tumors confirmed by MRI, and one needs surgery.I don't have health issues that make surgery or anesthesia too risky for me.The tumor to be removed is between 2.0 cm and 5.0 cm in size.I am medically fit for surgery and stereotactic radiosurgery (SRS).I am 18 years old or older.I can care for myself but may not be able to do active work.I agree to use birth control during the treatment.My cancer has spread to the lining of my brain and spinal cord.I have had radiation therapy to my brain.My brain metastases are not near the optic nerve or in the brainstem.
- Group 1: Arm II (stereotactic radiosurgery, surgery)
- Group 2: Arm I (surgery, stereotactic radiosurgery)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are people still being sought to participate in this clinical trial?
"This study is actively recruiting participants, according to the information on clinicaltrials.gov. The trial was first posted on 8/31/2022 and was last edited on 10/5/2022."
How many people are the researchers testing this on?
"That is correct, the online clinicaltrials.gov registry reflects that this study is currently open for recruitment. The trial was originally advertised on August 31st, 2022 and last updated October 5th, 2020. They are looking to enroll 236 individuals from 3 different centres."
Are there long-term risks to Arm II treatment?
"Arm II of the trial, which stereotactic radiosurgery and surgery, is considered safe. This is due to there being evidence from earlier phases that it is effective as well as multiple rounds of safety data."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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