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Clinical Trial Comparing Dose-intensified SBRT With Conventional Radiation Therapy for Spinal Metastases (DOSIS RCT)

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ClinicalTrials.gov Identifier: NCT02800551
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE April 29, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date November 2, 2018
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
Pain response - improvement by ≥ 2 points on the pain Visual Analogue Scale at 6 months post-treatment at the treatment site [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • Local metastasis control [ Time Frame: up to 2 years ]
    Local metastasis control is defined from the day of randomization to a day of local (at the site of the treated spinal metastasis) progression, i.e. local failure, determined on control MR images as a change in signal intensity or on CT images as increasing soft-tissue mass. Increased epidural disease or enlargement of paraspinal disease on control images will be documented as progression.
  • Overall survival [ Time Frame: up to 2 years ]
    Overall survival is defined from the day of randomization to a day of death of any cause.
  • Cancer-specific survival [ Time Frame: up to 2 years ]
    Cancer-specific survival is defined from the day of randomization to a day of death due to cancer progression.
  • Quality-of-life (QoL) [ Time Frame: Day 1 and last day of treatment (usually day5 if Radiotherapy is delivered in 5 fractions, and day 12 if Radiotherapy is delivered in 10 fractions); months 1, 3, 6, 9, 12, 18 and 24 ]
    Quality-of-life (QoL) as measured by the EORTC QLQ-C15-PL, EORTC-BM22 and EQ-5D-5L patient reported questionnaires
  • Epidural spinal cord compression [ Time Frame: up to 2 years ]
    Epidural spinal cord compression (ESCC) will be scored using Bilsky criteria.
  • Acute and late toxicity [ Time Frame: Acute toxicity: up to 3 months; late toxicity: from 3 months up to 24 months ]
    Acute aund late toxicity will be assessed in accordance to NCI CTCEA version 4.03 criteria.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Comparing Dose-intensified SBRT With Conventional Radiation Therapy for Spinal Metastases
Official Title  ICMJE Dose-intensified Image-guided Fractionated Stereotactic Body Radiation Therapy for Painful Spinal Metastases Versus Conventional Radiation Therapy: a Randomised Controlled Trial (DOSIS RCT)
Brief 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.
Detailed Description

Rationale: Radiation therapy is an effective palliative treatment for painful spinal metastases. A sub-group of patients with mass-type spinal metastases, a factor associated with poor local metastasis control, require treatment optimization ensuring durable pain control and metastatic tumor control.

Proposed solution: To intensify (escalate) radiation dose using simultaneous integrated boost with image-guided hypofractionated SBRT for painful mass-type spinal metastases in a randomized controlled trial. Two experimental fractionation regimes will be tested in the study depending on presence or absence of epidural involvement. Dose intensification is expected to achieve long-term pain control and long-term palliation as well as long-term local metastatic tumor control without adding toxicity as compared to conventional fractionation regimes with conventional radiation therapy.

The study will be carried out as multinational, multicentre phase II clinical controlled trial enrolling patients with painful mass-type spinal metastases who are eligible for radiation therapy without surgery. This study additionally includes a prospective observational arm for patients not eligible for randomisation who are treated in analogy to arm A of the randomised arm.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Metastasis
Intervention  ICMJE
  • Radiation: dose-intensified image-guided SBRT using simultaneous integrated boost
  • Radiation: External 3-dimensional conformal radiotherapy (3D-CRT)
Study Arms  ICMJE
  • Experimental: SBRT (Arm A)

    dose-intensified image-guided SBRT using simultaneous integrated boost:

    • in the case of no epidural involvement: 40 Gy and 20 Gy in 5 fractions to the high-dose and conventional-dose target volume, respectively.
    • In the case epidural involvement: 48.5 Gy and 30 Gy in 10 fractions to the high-dose and conventional-dose target volume, respectively.
    Intervention: Radiation: dose-intensified image-guided SBRT using simultaneous integrated boost
  • Active Comparator: Conventional Radiation Therapy (Arm B)

    External 3-dimensional conformal radiotherapy (3D-CRT):

    Homogeneous irradiation of the affected vertebra delivering either

    • 20 Gy in 5 fractions or
    • 30 Gy in 10 fractions.
    Intervention: Radiation: External 3-dimensional conformal radiotherapy (3D-CRT)
  • Experimental: SBRT (prospective observational)
    Patients eligible for the prospective observational arm will be treated according to the investigational arm (arm A) of the randomised arm of the trial.
    Intervention: Radiation: dose-intensified image-guided SBRT using simultaneous integrated boost
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 9, 2016)
146
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and 3 months after the end of treatment;
  • Mental conditions rendering the patient unable to understand the nature, scope, and possible consequences of the study;
  • Patient unlikely to comply with protocol, i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Indira Madani, Dr. +41 44 255 41 08 indira.madani@usz.ch
Contact: Antonia Schiess +41 44 255 41 08 antonia.schiess@usz.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800551
Other Study ID Numbers  ICMJE DOSIS RCT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Zurich
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Zurich
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias Guckenberger, Prof. Dr. Universitätsspital Zürich
PRS Account University of Zurich
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP