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Completed

NCT Number: NCT00974168

Spinal Cord Compression Re-Treat Study

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.

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Key information

Conditions

Pain Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Radiation Injuries Radiation Toxicity Signs and Symptoms Spinal Cord Compression Spinal Cord Diseases Spinal Cord Injuries Unspecified Adult Solid Tumor, Protocol Specific Wounds and Injuries

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saint Luke's Radiation Oncology Network, Dublin, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cumulative BED ≤ 100

Radiation

Radiation

Cumulative BED ≤ 130 Gy2

Radiation

Radiation

Primary outcomes

  1. Response to treatment as assessed by mobility via the Tomita mobility scale

    Time frame: 5 weeks after completion of radiation therapy

  2. Overall response rate (stabilization and response) (stage I)

    Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter

Secondary outcomes

  1. 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

  2. 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

  3. Pain control via the pain visual analogue score

    Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter

  4. 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

  5. Median survival (time from the date of recruitment/treatment to death)

    Time frame: Until death

Sponsors and collaborators

Lead sponsor

Cancer Trials Ireland

Network

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2016
Study completion
2018
First posted
Sep 10, 2009
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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