Spinal Cord Compression Re-Treat Study

Phase 2

Completed

• Conditions: Radiation Toxicity; Spinal Cord Compression; Pain; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Radiation: Cumulative BED ≤ 100; Radiation: Cumulative BED ≤ 130 Gy2

• Registration Number: NCT00974168
• Lead Sponsor: Cancer Trials Ireland

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-09-09
• Study First Submitted QC: 2009-09-09
• Study First Posted: 2009-09-10
• Primary Completion: 2016-12
• Status Verified: 2018-07
• Study Completion: 2018-09-27
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Cumulative BED ≤ 100	Radiation Cumulative BED ≤ 100 Gy2
B	Cumulative BED ≤ 130 Gy2	Cumulative BED ≤ 130 Gy2

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain control via the pain visual analogue score	5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Median survival (time from the date of recruitment/treatment to death)	Until death
Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system	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
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

Trial Locations

Locations (2)

Galway University Hospital; 🇮🇪 Galway, Ireland

Saint Luke's Radiation Oncology Network; 🇮🇪 Dublin, Ireland