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Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases
NA trial testing Stereotactic Radiosurgery in Malignant Neoplasm Brain in 24 participants. Completed in 22 July 2021.
| Lead sponsor | Christopher Wilke |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 December 2016 |
| Primary completion | 22 July 2021 |
| Estimated completion | 22 July 2021 |
| Sites | 1 location across United States |
Christopher Wilke
18 and older, any sex, with Malignant Neoplasm Brain. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 6 months compared to the tumor volume at the start of radiotherapy.
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 0.817 | 0.669 – 0.997 |
The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 12 months compared to the tumor volume at the start of radiotherapy.
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 0.817 | 0.669 – 0.997 |
The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 24 months compared to the tumor volume at the start of radiotherapy.
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 0.749 | 0.579 – 0.973 |
The probability of patients being alive at 6 months after the beginning of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 0.708 | 0.548 – 0.916 |
The probability of patients being alive at 12 months after the beginning of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 0.625 | 0.458 – 0.852 |
The probability of patients being alive at 24 months after the beginning of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 0.500 | 0.335 – 0.746 |
The probability of new brain metastases at 6 months identified via magnetic resonance imaging.
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 0.689 | 0.521 – 0.912 |
The probability of new brain metastases at 12 months identified via magnetic resonance imaging.
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 0.632 | 0.455 – 0.877 |
The probability of new brain metastases at 24 months identified via magnetic resonance imaging.
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 0.502 | 0.317 – 0.796 |
The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, sc
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 139.878 | ± 20.59528024 |
The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, sc
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 142.1581538 | ± 23.8429411 |
The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, sc
| Group | Value | 95% CI |
|---|---|---|
| Stereotactic Radiosurgery | 141.0952857 | ± 26.95376082 |
The primary goal of this research study is to determine the efficacy of giving pre-operative radiosurgery to patients pending resection of a brain metastasis.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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