NCT00974168

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2 pain

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_2 pain

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2018

Completed
Last Updated

July 29, 2019

Status Verified

July 1, 2018

Enrollment Period

9.2 years

First QC Date

September 9, 2009

Last Update Submit

July 26, 2019

Conditions

PainRadiation ToxicitySpinal Cord CompressionUnspecified Adult Solid Tumor, Protocol Specific

Keywords

painradiation toxicityspinal cord compressionunspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

A

ACTIVE COMPARATOR

Radiation Cumulative BED ≤ 100 Gy2

Radiation: Cumulative BED ≤ 100

B

ACTIVE COMPARATOR

Cumulative BED ≤ 130 Gy2

Radiation: Cumulative BED ≤ 130 Gy2

Interventions

Cumulative BED ≤ 100RADIATION

Radiation

A
Cumulative BED ≤ 130 Gy2RADIATION

Radiation

B

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Saint Luke's Radiation Oncology Network

Dublin, 6, Ireland

Location

Galway University Hospital

Galway, Ireland

Location

Related Publications (1)

  • Wallace ND, Dunne MT, McArdle O, Small C, Parker I, Shannon AM, Clayton-Lea A, Parker M, Collins CD, Armstrong JG, Gillham C, Coffey J, Fitzpatrick D, Salib O, Moriarty M, Stevenson MR, Alvarez-Iglesias A, McCague M, Thirion PG. Efficacy and toxicity of primary re-irradiation for malignant spinal cord compression based on radiobiological modelling: a phase II clinical trial. Br J Cancer. 2023 Feb;128(4):576-585. doi: 10.1038/s41416-022-02078-w. Epub 2022 Dec 8.

    PMID: 36482188DERIVED

MeSH Terms

Conditions

PainRadiation InjuriesSpinal Cord Compression

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and InjuriesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord Injuries

Study Officials

  • Pierre Thirion, Dr

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

October 1, 2007

Primary Completion

December 1, 2016

Study Completion

September 27, 2018

Last Updated

July 29, 2019

Record last verified: 2018-07

Locations

IE(2)