PainPhase 2NCT00974168
Spinal Cord Compression Re-Treat Study
A Phase 2 study testing Cumulative BED ≤ 100 and Cumulative BED ≤ 130 Gy2 in people with Pain and Radiation Toxicity, run by Cancer Trials Ireland at 2 sites in Ireland.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pain, Radiation Toxicity, Spinal Cord Compression
- What is being tested?
- Cumulative BED ≤ 100 and Cumulative BED ≤ 130 Gy2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesIreland
- Study dates
- Oct 2007to 27 Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
Ireland2 sites
Saint Luke's Radiation Oncology Network
Dublin, 6
Galway University Hospital
Galway
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Radiation Toxicity, Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- Cumulative BED ≤ 100, Cumulative BED ≤ 130 Gy2
- Keywords
- pain, radiation toxicity, spinal cord compression, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Pain, Radiation Injuries, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cumulative BED ≤ 100Radiation
Radiation
Cumulative BED ≤ 130 Gy2Radiation
Radiation
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Radiation Cumulative BED ≤ 100 Gy2 Receives: Radiation: Cumulative BED ≤ 100 |
| B | Active comparator | Cumulative BED ≤ 130 Gy2 Receives: Radiation: Cumulative BED ≤ 130 Gy2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment as assessed by mobility via the Tomita mobility scale
Measured: 5 weeks after completion of radiation therapy
Overall response rate (stabilization and response) (stage I)
Measured: 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
Measured: 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
Measured: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Pain control via the pain visual analogue score
Measured: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire
Measured: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Median survival (time from the date of recruitment/treatment to death)
Measured: Until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startOct 2007
- Primary completionDec 2016
- Study completion27 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pierre Thirion, Dr, Principal investigator, Saint Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974168
- Sponsor's protocol ID
- CTRIAL-IE (ICORG) 07-11
- Other IDs
- ICORG 07-11, EU-20953
- Status last verified
- Jul 2018
- First submitted
- 9 Sep 2009
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36482188
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial Evaluating the Efficacy of a Radio-Biological Based Re-Irradiation Strategy for Patients With Malignant Spinal Cord Compression
- ClinicalTrials.gov ID
- NCT00974168
- Acronym / sponsor ID
- CTRIAL-IE (ICORG) 07-11
- Conditions
- Pain, Radiation Toxicity, Spinal Cord Compression, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- pain, radiation toxicity, spinal cord compression, unspecified adult solid tumor, protocol specific
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Oct 2007
- Primary completion
- Dec 2016 (actual)
- Study completion
- 27 Sep 2018 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Radiation: Cumulative BED ≤ 100Radiation Cumulative BED ≤ 100 Gy2 |
| B | Active comparator | Radiation: Cumulative BED ≤ 130 Gy2Cumulative BED ≤ 130 Gy2 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cumulative BED ≤ 100Radiation | Radiation | A |
| Cumulative BED ≤ 130 Gy2Radiation | Radiation | B |
Primary outcome
Response to treatment as assessed by mobility via the Tomita mobility scale
Time frame: 5 weeks after completion of radiation therapy
Overall response rate (stabilization and response) (stage I)
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
5 secondary outcomes
Incidence of radiation-induced myelopathy via the RTOG SOMA morbidity grading system
Time frame: 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
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Pain control via the pain visual analogue score
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Quality of life via the EORTC QLQ-C15 PAL version 1.0 questionnaire
Time frame: 5 weeks subsequent to radiation therapy and 3 monthly timepoints thereafter
Median survival (time from the date of recruitment/treatment to death)
Time frame: Until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Derived from this study: PubMed 36482188Wallace 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Thirion, Dr principal investigator
Saint Luke's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cumulative BED ≤ 100 and Cumulative BED ≤ 130 Gy2 in people with Pain and Radiation Toxicity, run by Cancer Trials Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment as assessed by mobility via the Tomita mobility scale (time frame: 5 weeks after completion of radiation therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00974168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.