---
title: Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost
nct_id: NCT01849510
overall_status: UNKNOWN
phase: PHASE2
sponsor: University of Erlangen-Nürnberg Medical School
study_type: INTERVENTIONAL
primary_condition: Spinal Metastases
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01849510.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01849510"
ct_last_update_post_date: 2017-08-11
last_seen_at: "2026-05-12T06:54:32.313Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy of Dose Intensified Radiotherapy of Spinal Metastases by Hypofractionated Radiation and IGRT hfSRT Mediated Boost

**Official Title:** Efficacy of Dose Intensified Radiotherapy of Spinal Metastases of Solid Tumors by Dose Increased, Homogeneous Radiation of Vertebral Body and Simultaneous Application of Stereotactic Boost.

**NCT ID:** [NCT01849510](https://clinicaltrials.gov/study/NCT01849510)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 155
- **Lead Sponsor:** University of Erlangen-Nürnberg Medical School
- **Conditions:** Spinal Metastases
- **Start Date:** 2013-03
- **Completion Date:** 2019-04
- **CT.gov Last Update:** 2017-08-11

## Brief Summary

Spinal metastases indicate for an incurable course of disease. Local tumor control after palliative radiotherapy of spinal metastases (10x3 Gy, 1x8Gy) is between 61 to 81%. In 30% of patients, therapy fails locally within two years associated with further symptoms that are difficult to treat, because a further radiation of already radiated vertebra leads to a higher rate of myelitis. This trial aims to improve local tumor control and control of pain by radiotherapy with increase in total and single dose. Dose elevation is realized by simultaneous, integrated boost mediated by image-guided stereotactic radiotherapy (IGRT \& hfSRT) and by elevation of elective dose in vertebral body with 12x3 Gy (standard: 10x3 Gy). Primary endpoint is local tumor control (time up to progression). Secondary endpoints are pain control associated with quality of live, severity of acute and chronic adverse effects and overall survival. It is planned to recruit a total number of 155 patients.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* minimum age 18
* expectance of life at least 6 months
* Karnofsky-Score \> 50
* 1-3 vertebral body metastases
* Up to 5 other, macroscopic metastases
* effective contraception
* geographic reachability of patients
* Signed study-specific consent form prior to therapy
* no on-treatment participation on other trials

Exclusion Criteria:

* initial required neurosurgical decompression
* rapid, neurological deterioration
* prior radiotherapy of region for planned radiation
* conditions that preclude the application of magnetic resonance tomography
* malignancy: multiple myeloma or lymphoma
* technical conditions preclude stereotactic irradiation (technical limitations of device)
* pregnant or nursing women
* Fertile patients who refuse effective contraception during study treatment
* persistent drug and/or alcohol abuse
* patients that are not able or willing to behave according to study protocol
* absent attendance for personal, disease related data storage and transfer
* on-treatment participation on other trials
```

## Arms

- **dose intensified** (EXPERIMENTAL) — hypofractionated 12x3 Gy + integrated boost 12x4 Gy
- **standard** (ACTIVE_COMPARATOR) — hypofractionated 10x3 Gy

## Interventions

- **hypofractionated 12x3 Gy + integrated boost 12x4 Gy** (RADIATION) — hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT \& hfSRT
- **hypofractionated 10x3 Gy** (RADIATION) — hypofractionated, homogeneous radiation (10x3 Gy)

## Primary Outcomes

- **tumor control (time up to progression)** _(time frame: up to progression (MR-imaging), max. 5 years after therapy)_

## Secondary Outcomes

- **severity of acute and chronic adverse effects** _(time frame: acute: assessment up to 6 weeks after therapy; chronic: assessment up to 60 months after therapy or up to progression)_
- **overall survival** _(time frame: assessment 60 months after therapy or up to death)_
- **pain control** _(time frame: assessment 60 months after therapy)_

## Locations (3)

- Universitätsklinikum Erlangen, Erlangen, Germany — _RECRUITING_
- Universitätsklinikum Frankfurt; Strahlentherapie, Frankfurt/M., Germany — _RECRUITING_
- Universitätsklinikum Regensburg, Strahlentherapie, Regensburg, Germany — _RECRUITING_

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.universitätsklinikum erlangen|erlangen||germany` — added _(2026-05-12)_
- `locations.universitätsklinikum frankfurt; strahlentherapie|frankfurt/m.||germany` — added _(2026-05-12)_
- `locations.universitätsklinikum regensburg, strahlentherapie|regensburg||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01849510.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01849510*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*