Clinical Trial Comparing Dose-intensified SBRT With Conventional Radiation Therapy for Spinal Met… (NCT02800551) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial Comparing Dose-intensified SBRT With Conventional Radiation Therapy for Spinal Metastases
Switzerland219 participantsStarted 2016-07-08
Plain-language summary
This study will compare pain (primary end-point) and local metastatic tumor control (secondary end-point) after dose-intensified image-guided fractionated stereotactic body radiation therapy (SBRT) for painful mass-type spinal metastases versus conventional radiation therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Established histological diagnosis of a malignant primary or metastatic tumor;
* Histologically, radiologically or scintigraphically proven spinal metastasis;
* Pain in the affected spinal region or free of pain under pain medication;
* Age ≥18 years old;
* Karnofsky performance status ≥60%;
* Written informed consent.
Exclusion Criteria:
* Modified Bauer Score \< 2;
* No-mass-type metastatic lesion, defined as a 3D space-occupying lesion visible on CT and/or MR;
* "Radiosensitive" histology of the primary tumor, e.g., lymphoma, small-cell lung cancer, multiple myeloma, germ cell tumors;
* Progressive neurological symptoms/deficit;
* More than 3 affected vertebrae in one target site;
* More than 2 treatment sites;
* Spinal Instability Neoplastic Score (SINS) 13 - 18, i.e., unstable;
* Unable to tolerate treatment (unable to lie flat and immobilized);
* Previous radiotherapy of the region at the level of the affected vertebrae;
* Previous radionuclide therapy within 30 days before stereotactic body radiation therapy;
* Previous surgery (stabilization) of the affected vertebrae;
* Contraindications for MR scanning, e.g., pacemakers;
* Patients with allergy to contrast agents used in computer tomography (CT) and magnetic resonance (MR) imaging or patients who cannot be premedicated to use contrast agent;
* Pregnant or lactating women;
* Women of child bearing potential or sexually active males not willing to use effective contraception while on treatment…
What they're measuring
1
Pain response - improvement by ≥ 2 points on the pain Visual Analogue Scale at 6 months post-treatment at the treatment site