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Reduction of Pain Symptoms With Stereotactic Radiotherapy on Bone Metastases

NCT03597984 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2019-07-05

No results posted yet for this study

Summary

Interventional study without medicinal, randomized 1: 1 open-label, multicenter, phase 3 to evaluate the response in terms of reduction of pain symptomatology from bone metastases, comparing the conformational radiotherapy (3D-CRT) administered in conventional fractionation vs. extracranial stereotactic radiotherapy (SBRT) administered with concomitant integrated simultaneous boost (Simultaneous Integrated Boost-SIB)

Conditions

Interventions

RADIATION

Simultaneous Integrated Boost-SIB on macroscopic metastases

Delivery of a boost on macroscopic secondary lesion with Simultaneous Integrated Boost technique according this schedule: \- 5 Gy x 3 fr (Whole Vertebra) + SIB 10 Gy x 3 fr on the macroscopic disease Gross Tumor Volume - (GTV)

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Principal Investigators

  • Francesco Cellini, MD · Fondazione Policlinico Gemelli IRCCS - Roma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2019-07-01
Completion
2020-12-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03597984 on ClinicalTrials.gov