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Radiotherapy for Solid Tumor Spine Metastases
Phase 2 trial testing Post-operative, Stereotactic Body Radiation Therapy (SBRT) in Solid Tumor Spine Metastases in 35 participants. Completed in 27 July 2018.
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 20 May 2013 |
| Primary completion | 2 April 2018 |
| Estimated completion | 27 July 2018 |
| Sites | 1 location across United States |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →
Adults 12 to 100, any sex, with Solid Tumor Spine Metastases. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To estimate the rate of radiographic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 3 |
To estimate the time (in months) to radiographic local recurrence in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 3.5 | 3.4 – 5.8 |
To estimate the rate of re-treatment at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 2 |
To estimate the rate of symptomatic local recurrence at 12 months in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 31 |
Number of participants experiencing radiation myelopathy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 0 |
Number of participants treated with a post-operative stereotactic radiosurgery boost for resected spine metastases, experiencing wound dehiscence.
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 0 |
Time in months to return to chemotherapy in patients treated with a post-operative stereotactic radiosurgery boost for resected spine metastases.
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 0.5 | 0 – 9.4 |
To evaluate the post-treatment symptomatic local recurrence in patients with radio-sensitive tumors.
| Group | Value | 95% CI |
|---|---|---|
| Treatment | 3 |
Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment |
|---|---|---|
| Fatigue | General disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Depression | Psychiatric disorders | — |
| Anorexia | Psychiatric disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Agitation | Psychiatric disorders | — |
| Anxiety | Psychiatric disorders | — |
| Neuralgia | Musculoskeletal and connective tissue disorders | — |
| Weight loss | Metabolism and nutrition disorders | — |
| Dry mouth | General disorders | — |
| Stomach pain | Gastrointestinal disorders | — |
| Bloating | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Tremor | Nervous system disorders | — |
| Concentration impairment | General disorders | — |
| White blood cell count decreased | Blood and lymphatic system disorders | — |
| Cough | General disorders | — |
| Dizziness | General disorders | — |
| Lymphocytes absolute decreased | Blood and lymphatic system disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Malaise | General disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Gastritis | Gastrointestinal disorders | — |
| Headache | General disorders | — |
| Lymphocyte count decreased | Blood and lymphatic system disorders | — |
| Pain | General disorders | — |
| Platelet count decreased | Blood and lymphatic system disorders | — |
| Insomnia | General disorders | — |
| AST increased | Gastrointestinal disorders | — |
| Dyphagia | Nervous system disorders | — |
| Localized edema | Metabolism and nutrition disorders | — |
| Akathisia | Psychiatric disorders | — |
| Alkaline phosphatase increased | Metabolism and nutrition disorders | — |
| Chills rigors | General disorders | — |
| Edema extremities | Metabolism and nutrition disorders | — |
| Pain due to RT | Surgical and medical procedures | — |
Data from ClinicalTrials.gov NCT01752036 adverse events section.
Although it is being increasingly used off protocol, there is minimal data regarding the efficacy of stereotactic radiosurgery to the tumor bed following surgical resection of metastatic lesions to the spine. The primary objective of this study is to evaluate radiographic local recurrence in the tumor bed following stereotactic radiosurgery compared to the expected rate following conventional radiation therapy.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing