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Spinal Cord Compression Re-Treat Study

Primary Purpose

Pain, Radiation Toxicity, Spinal Cord Compression

Status
Completed
Phase
Phase 2
Locations
Ireland
Study Type
Interventional
Intervention
Cumulative BED ≤ 100
Cumulative BED ≤ 130 Gy2
Sponsored by
Cancer Trials Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, radiation toxicity, spinal cord compression, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • MRI-confirmed diagnosis of malignant spinal cord compression

    • MRI of the entire spine performed
  • Histologically proven malignancy

    • No primary tumors of the spine or vertebral column
  • Undergone previous radiotherapy to the involved area of the spinal cord (e.g., full segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated)

    • Maximum biologically effective dose received from previous irradiation ≤ 90 Gy_2
  • Deemed not suitable for neurosurgical intervention at the time of initial assessment

    • Patients deemed inoperable are eligible

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 40-100%
  • Short life expectancy
  • No medical or psychiatric condition that, in the opinion of the investigator or research team, contraindicates participation in this study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Sites / Locations

  • Saint Luke's Radiation Oncology Network
  • Galway University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Radiation Cumulative BED ≤ 100 Gy2

Cumulative BED ≤ 130 Gy2

Outcomes

Primary Outcome Measures

Response to treatment as assessed by mobility via the Tomita mobility scale
Overall response rate (stabilization and response) (stage I)

Secondary Outcome Measures

Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system
Toxicity other than spine (acute toxicity assessed at weeks 1 and 5 and late toxicity assessed at 3 months and at subsequent follow-ups) evaluated according to RTOG criteria
Pain control via the pain visual analogue score
Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire
Median survival (time from the date of recruitment/treatment to death)

Full Information

First Posted
September 9, 2009
Last Updated
July 26, 2019
Sponsor
Cancer Trials Ireland
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1. Study Identification

Unique Protocol Identification Number
NCT00974168
Brief Title
Spinal Cord Compression Re-Treat Study
Official Title
A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
September 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Trials Ireland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may be effective in treating malignant spinal cord compression in patients who have received previous radiation therapy to the spine. PURPOSE: This phase II trial is studying radiation therapy in treating patients with malignant spinal cord compression.
Detailed Description
OBJECTIVES: Primary To determine the efficacy of a biologically effective dose-based re-irradiation strategy, in terms of the response rate (based on the mobility score using the Tomita scale where improvement in mobility or stable mobility score will be regarded as a response) in patients with malignant spinal cord compression. Secondary To determine quality of life as assessed by the EORTC QLQ-C15 PAL version 1.0 questionnaire. To determine the non-spinal radiation-induced toxicity using standard RTOG criteria. To determine the rate of long-term spinal toxicity and radiation-induced myelopathy using the RTOG SOMA morbidity grading system. OUTLINE: Patients are divided into 2 groups according to the interval since their most recent radiotherapy to the involved area of the spinal cord. Group 1 (< 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative biologically effective dose (BED) ≤ 100 Gy_2 in addition to receiving other current treatment. Group 2 (≥ 6 months since prior radiotherapy): Patients undergo radiotherapy for a cumulative BED ≤ 130 Gy_2 in addition to receiving other current treatment. Mobility score is assessed and patients complete a quality-of-life assessment at baseline and at each follow-up visit starting at week 5. After completion of study treatment, patients are followed up at 1 and 5 weeks, at 3 months, and then every 3 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Radiation Toxicity, Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
pain, radiation toxicity, spinal cord compression, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Radiation Cumulative BED ≤ 100 Gy2
Arm Title
B
Arm Type
Active Comparator
Arm Description
Cumulative BED ≤ 130 Gy2
Intervention Type
Radiation
Intervention Name(s)
Cumulative BED ≤ 100
Intervention Description
Radiation
Intervention Type
Radiation
Intervention Name(s)
Cumulative BED ≤ 130 Gy2
Intervention Description
Radiation
Primary Outcome Measure Information:
Title
Response to treatment as assessed by mobility via the Tomita mobility scale
Time Frame
5 weeks after completion of radiation therapy
Title
Overall response rate (stabilization and response) (stage I)
Time Frame
5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Secondary Outcome Measure Information:
Title
Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system
Time Frame
5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Title
Toxicity other than spine (acute toxicity assessed at weeks 1 and 5 and late toxicity assessed at 3 months and at subsequent follow-ups) evaluated according to RTOG criteria
Time Frame
5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Title
Pain control via the pain visual analogue score
Time Frame
5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Title
Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire
Time Frame
5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Title
Median survival (time from the date of recruitment/treatment to death)
Time Frame
Until death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: MRI-confirmed diagnosis of malignant spinal cord compression MRI of the entire spine performed Histologically proven malignancy No primary tumors of the spine or vertebral column Undergone previous radiotherapy to the involved area of the spinal cord (e.g., full segment and/or ≥ 2 cm in cranio-caudal of overlap between the 2 areas treated) Maximum biologically effective dose received from previous irradiation ≤ 90 Gy_2 Deemed not suitable for neurosurgical intervention at the time of initial assessment Patients deemed inoperable are eligible PATIENT CHARACTERISTICS: Karnofsky performance status 40-100% Short life expectancy No medical or psychiatric condition that, in the opinion of the investigator or research team, contraindicates participation in this study PRIOR CONCURRENT THERAPY: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Thirion, Dr
Organizational Affiliation
Saint Luke's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Luke's Radiation Oncology Network
City
Dublin
ZIP/Postal Code
6
Country
Ireland
Facility Name
Galway University Hospital
City
Galway
Country
Ireland

12. IPD Sharing Statement

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Spinal Cord Compression Re-Treat Study

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