NCT03741673 Pre-operative SRS or Post-operative SRS in Treating Cancer Patients With Brain Metastases
| NCT ID | NCT03741673 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Malignant Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2018-11-08 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2018-11-08 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase III trial studies stereotactic radiosurgery (SRS) before surgery to see how well it works compared with SRS after surgery in treating patients with cancer that has spread to the brain (brain metastases). SRS is the delivery of focused, high-dose radiation given in a single session to the tumors, with a minimal dose given to uninvolved areas of the brain.
Eligibility Criteria
Inclusion Criteria: * The primary lesion pre-operatively can have a maximum diameter of =\< 4 cm for single fraction and =\< 7 cm for multifraction therapy * Patients must be considered candidates for SRS within +/- 30 days of surgical resection as defined by either history and physical (H\&P) or presentation at brain metastasis tumor board conference note * Patients must have a Karnofsky performance scores \>= 70 or Eastern Cooperative Oncology Group (ECOG) \>= 2 within 30 days of enrollment * Patients must agree to randomization as documented by signing the Institutional Review Board (IRB) approved consent form * No radiographic evidence of leptomeningeal disease on MD Anderson Cancer Center (MDACC) departmental radiology report or study neuro-radiologist review * Documented history of malignancy Exclusion Criteria: * Patients who have received prior radiation therapy to the brain for any reason * The primary tumor is small-cell lung cancer, lymphoma, leukemia, or multiple myeloma * For females, if they are pregnant or breast-feeding (The exclusion is made because gadolinium may be teratogenic in pregnancy)
Contact & Investigator
Debra N Yeboa
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT03741673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03741673 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT03741673 currently recruiting?
Yes, NCT03741673 is actively recruiting participants. Contact the research team at dnyeboa@mdanderson.org for enrollment information.
Where is the NCT03741673 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT03741673 clinical trial?
NCT03741673 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Debra N Yeboa at M.D. Anderson Cancer Center. The trial plans to enroll 180 participants.