Spinal Cord Compression Re-Treat Study

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974168
• Other study ID #: CTRIAL-IE (ICORG) 07-11
• Secondary ID: ICORG 07-11EU-20
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Est. completion date: September 27, 2018

Study information

• Verified date: July 2018
• Source: Cancer Trials Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00624507

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 27, 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Radiation Injuries
• Radiation Toxicity
• Spinal Cord Compression
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Radiation:
• Cumulative BED = 100
Radiation
• Cumulative BED = 130 Gy2
Radiation

Locations

Country	Name	City	State
Ireland	Saint Luke's Radiation Oncology Network	Dublin
Ireland	Galway University Hospital	Galway

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Trials Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment as assessed by mobility via the Tomita mobility scale		5 weeks after completion of radiation therapy
Primary	Overall response rate (stabilization and response) (stage I)		5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Secondary	Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system		5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Secondary	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		5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Secondary	Pain control via the pain visual analogue score		5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Secondary	Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire		5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Secondary	Median survival (time from the date of recruitment/treatment to death)		Until death