Radiation Therapy in Treating Patients With Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy. ICORG 07-11

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by ICORG- All Ireland Cooperative Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00974168
First received: September 9, 2009
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Pain
Radiation Toxicity
Spinal Cord Compression
Unspecified Adult Solid Tumor, Protocol Specific
Radiation: Cumulative BED ≤ 100
Radiation: Cumulative BED ≤ 130 Gy2
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression

Resource links provided by NLM:


Further study details as provided by ICORG- All Ireland Cooperative Oncology Research Group:

Primary Outcome Measures:
  • Response to treatment as assessed by mobility via the Tomita mobility scale [ Time Frame: 5 weeks after completion of radiation therapy ] [ Designated as safety issue: No ]
  • Overall response rate (stabilization and response) (stage I) [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Pain control via the pain visual analogue score [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Median survival (time from the date of recruitment/treatment to death) [ Time Frame: Until death ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: October 2007
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Radiation Cumulative BED ≤ 100 Gy2
Radiation: Cumulative BED ≤ 100
Radiation
Active Comparator: B
Cumulative BED ≤ 130 Gy2
Radiation: Cumulative BED ≤ 130 Gy2
Radiation

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974168

Locations
Ireland
Saint Luke's Radiation Oncology Network Recruiting
Dublin, Ireland, 6
Contact: Pierre Thirion, MD    353-1-406-5000      
Galway University Hospital Recruiting
Galway, Ireland
Contact: Cormac Small    353-91-893-487      
Sponsors and Collaborators
ICORG- All Ireland Cooperative Oncology Research Group
Investigators
Principal Investigator: Pierre Thirion, MD Saint Luke's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: ICORG- All Ireland Cooperative Oncology Research Group
ClinicalTrials.gov Identifier: NCT00974168     History of Changes
Obsolete Identifiers: NCT00624507
Other Study ID Numbers: CDR0000644385, ICORG-07-11, EU-20953
Study First Received: September 9, 2009
Last Updated: August 11, 2014
Health Authority: Ireland: Irish Medicines Board

Keywords provided by ICORG- All Ireland Cooperative Oncology Research Group:
pain
radiation toxicity
spinal cord compression
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Spinal Cord Compression
Radiation Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014