Spinal Cord Compression Re-Treat Study

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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Unspecified Adult Solid Tumor, Protocol Specific; Radiation Toxicity; Spinal Cord Compression
• Intervention / Treatment: Radiation: Cumulative BED ≤ 100; Radiation: Cumulative BED ≤ 130 Gy2

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland, 6
    • Saint Luke's Radiation Oncology Network
  • Galway, Ireland
    • Galway University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; Radiation Cumulative BED ≤ 100 Gy2	Radiation: Cumulative BED ≤ 100; Radiation
Active Comparator: B; Cumulative BED ≤ 130 Gy2	Radiation: Cumulative BED ≤ 130 Gy2; Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response to treatment as assessed by mobility via the Tomita mobility scale	5 weeks after completion of radiation therapy
Overall response rate (stabilization and response) (stage I)	5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system	5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
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
Pain control via the pain visual analogue score	5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire	5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Median survival (time from the date of recruitment/treatment to death)	Until death

Collaborators and Investigators

• Sponsor: Cancer Trials Ireland
• Investigators: Principal Investigator: Pierre Thirion, Dr, Saint Luke's Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): September 27, 2018

Study Registration Dates

• First Submitted: September 9, 2009
• First Submitted That Met QC Criteria: September 9, 2009
• First Posted (Estimate): September 10, 2009

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: unspecified adult solid tumor, protocol specific; pain; radiation toxicity; spinal cord compression
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Spinal Cord Diseases; Spinal Cord Injuries; Spinal Cord Compression
• Other Study ID Numbers: CTRIAL-IE (ICORG) 07-11; ICORG 07-11; EU-20953