Spinal Cord Compression Re-Treat Study

Cancer Trials Ireland

Status and phase

Completed

Phase 2

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Radiation Toxicity

Spinal Cord Compression

Pain

Treatments

Radiation: Cumulative BED ≤ 100

Radiation: Cumulative BED ≤ 130 Gy2

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00974168

CTRIAL-IE (ICORG) 07-11

ICORG 07-11

EU-20953

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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: