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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression

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 Summary:

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 tr
Sponsor: Cancer Trials Ireland

Current Primary Outcome:

  • Response to treatment as assessed by mobility via the Tomita mobility scale [ Time Frame: 5 weeks after completion of radiation therapy ]
  • Overall response rate (stabilization and response) (stage I) [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]


Original Primary Outcome:

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


Current Secondary Outcome:

  • 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 ]
  • 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 ]
  • Pain control via the pain visual analogue score [ Time Frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter ]
  • 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 ]
  • Median survival (time from the date of recruitment/treatment to death) [ Time Frame: Until death ]


Original Secondary Outcome:

  • 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)


Information By: Cancer Trials Ireland

Dates:
Date Received: September 9, 2009
Date Started: October 2007
Date Completion:
Last Updated: December 20, 2016
Last Verified: December 2016