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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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