Clinical trial NCT00974168: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Cancer Trials Ireland
Sponsor class: NETWORK
First posted: 2009-09-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response to treatment as assessed by mobility via the Tomita mobility scale
timeFrame: 5 weeks after completion of radiation therapy
measure: Overall response rate (stabilization and response) (stage I)
timeFrame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Secondary outcomes:
measure: Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system
timeFrame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
measure: 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
timeFrame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
measure: Pain control via the pain visual analogue score
timeFrame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
measure: Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire
timeFrame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
measure: Median survival (time from the date of recruitment/treatment to death)
timeFrame: Until death
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Saint Luke's Radiation Oncology Network
city: Galway
country: Ireland
facility: Galway University Hospital
Study officials:
affiliation: Saint Luke's Hospital
name: Pierre Thirion, Dr
role: PRINCIPAL_INVESTIGATOR
References: