Radiation Therapy in Treating Patients With Malignant Spinal Cord Compression Who Were Previously Treated With Radiation Therapy

Condition(s) targeted: Pain; Radiation Toxicity; Spinal Cord Compression; Unspecified Adult Solid Tumor, Protocol Specific

Intervention: quality-of-life assessment (Procedure); radiation therapy (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: Ireland Cooperative Oncology Research Group

Official(s) and/or principal investigator(s):
Pierre Thirion, MD, Principal Investigator, Affiliation: Saint Luke's Hospital

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.

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 design: Treatment, Open Label

Primary outcome:

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

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

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)

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Saint Luke's Hospital, Dublin 6, Ireland; Recruiting
Pierre Thirion, MD, Phone: 353-1-406-5000

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 2007
Last updated: October 7, 2009