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Study Comparing Stereotactic Body Radiotherapy vs Conventional Palliative Radiotherapy (CRT) for Spinal Metastases

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ClinicalTrials.gov Identifier: NCT02512965
Recruitment Status : Active, not recruiting
First Posted : July 31, 2015
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
Trans-Tasman Radiation Oncology Group (TROG)
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Brief Summary:
The purpose of this study is to find out if SBRT is better than CRT at controlling pain in the spine 3 months after receiving treatment.

Condition or disease Intervention/treatment Phase
Spinal Metastases Radiation: 20 Gy in 5 fractions Radiation: Conventional SBRT: 24 Gy in 2 fractions Not Applicable

Detailed Description:
This research is being done because while there is some evidence suggesting that SBRT may improve treatment for patients with spine metastases, more research is needed to determine if it is better than CRT. The first part of the randomized trial (phase II) looked at whether it was possible (feasible) to provide these treatments in cancer centres across Canada, by aiming to recruit 54 participants within 18 months. This part of the study was successfully completed in early 2017. The second component of this study, called a randomized phase III trial, is now underway. It involves recruiting another 124 participants to receive either CRT or SBRT, using the same study procedure as in the feasibility study. We will continue to obtain information about whether SBRT is better than CRT at controlling pain.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Phase II/III Study Comparing Stereotactic Body Radiotherapy(SBRT) Versus Conventional Palliative Radiotherapy (CRT) for Patients With Spinal Metastases
Actual Study Start Date : July 28, 2015
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Arm Intervention/treatment
Active Comparator: Standard Conventional Radiotherapy
Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions
Radiation: 20 Gy in 5 fractions
Experimental: Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions
Radiation: Conventional SBRT: 24 Gy in 2 fractions



Primary Outcome Measures :
  1. The ability to randomize 54 patients with spinal metastases in Phase 2 measured by number of patients randomized to the trial [ Time Frame: 18 months ]
  2. Phase III: Complete pain response at 3 months post-radiation measured by the Cochran-Mantel-Hanzeal test [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Complete pain response based on the International Bone Metastases Consensus Working Party Criteria [ Time Frame: 6 months post radiation ]
  2. Radiation site progression-free survival using MRI imaging [ Time Frame: 3 and 6 months post radiation ]
  3. Number and severity of adverse events using the Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) [ Time Frame: 3 and 6 months post radiation ]
  4. Health-related Quality of Life measured by the Bone Metastases Module (QLQ-BM22) instrument [ Time Frame: 3 and 6 months post radiation ]
  5. Health-related Quality of Life measured by the EORTC QLQ-C30 instrument [ Time Frame: 3 and 6 months post radiation ]
  6. Economic analysis as measured by the EuroQoL Health Questionnaire (EQ-5D-5L) instrument [ Time Frame: 3 and 6 months post radiation ]
  7. Radiotherapy Quality Assurance compliance consisting of investigator credentialing, Prospective centre based individual pre-treatment case review and Retrospective external individual post-treatment case review. [ Time Frame: Immediately pre and immediately post treatment ]
  8. Overall Survival [ Time Frame: 3 and 6 months post radiation ]
  9. Spinal Instability Neoplastic Score [ Time Frame: 3 and 6 months post radiation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic or cytologic diagnosis of cancer (excluding seminoma, small cell lung cancer and hematologic primaries).
  • Spinal metastasis documented with MRI and suitable for treatment with radiotherapy with the following characteristics:

    • Painful, as defined by a pain score ≥ 2 for worst pain in the planned target treatment volume;
    • ≤ 3 consecutive spinal segments involved by tumour to be included in the planned target volume. The patient may have other spinal metaastases to be treated as per the radiation oncologist's discretion, but the eligible spinal metastatic site has to be one where there is pain and no more than 3 consecutive segments to be included as clinical target volume and appropriate for either 20 Gy in 5 fractions or 24 Gy in 2 fractions per the randomization.
  • There is no plan to change the pain medication on the first day of protocol treatment with radiotherapy.
  • ECOG Performance Status 0-2.
  • Seen by a radiation oncologist and judged to be appropriate for participation in this study including ability to tolerate protocol radiotherapy (SBRT or CRT).
  • Age of 18 years or older.
  • Patient is able and willing to complete the Patient Diary (pain and analgesic use).
  • Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life questionnaire in either English or French. The baseline assessment must be completed within required timelines, prior to randomization. Inability (illiteracy in English or French, loss of sight, or other equivalent reason) to complete the questionnaires will not make the patient ineligible for the study. However, ability but unwillingness to complete the questionnaires will make the patient ineligible.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • In accordance with CCTG policy, protocol treatment is to begin within 3 weeks of patient randomization. From the time of successful treatment planning, no more than 12 days can elapse before the first fraction of radiotherapy is delivered.
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.
  • Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin is high and partner is vasectomized, it may be associated with tumour production of hCG, as seen with some cancers. Patient will be considered eligible if an ultrasound is negative for pregnancy.

Exclusion Criteria:

  • Patients who have a pacemaker, such that MRI cannot be performed or treatment cannot be delivered safely.
  • Patients with prior treatment with any radionuclide within 30 days prior to randomization.
  • Patients with prior radiation to the spinal segment intended to be treated with protocol radiotherapy such that the protocol therapy cannot be delivered as intended.
  • Patients with prior surgery to the spinal segment intended to be treated with protocol radiotherapy.
  • Patients who have received chemotherapy within 1 week prior to administration of protocol radiotherapy or who are expected/planned to receive chemotherapy within one week of completing protocol radiotherapy. Centre guidelines regarding administration of targeted non-cytotoxic therapy must be followed with the proviso that no systemic anticancer therapy should be administered within 24 hours prior to and post-radiotherapy. Endocrine therapy may be administered during radiotherapy as per the discretion of the treating physician.
  • Patients with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of more than 12.
  • Patients with symptomatic spinal cord compression or cauda equina syndrome resulting from bony compression or epidural compression of the spinal cord and cauda equina, respectively. Symptomatic refers to neurolic deficit in the form of motor, bowel or bladder dysfunction.
  • Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512965


Locations
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Australia, Aucklund
Auckland City Hospital
Grafton, Aucklund, Australia, 1023
Australia, New South Wales
Liverpool Cancer Therapy Centre, Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Australia, Queensland
Princess Alexandra Hospital
Brisbane, Queensland, Australia, 4102
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Peter McCallum Cancer Institute
Melbourne, Victoria, Australia, 3002
Peter Mac - Sunshine Hospital
St Albans, Victoria, Australia, 3021
Australia
Canberra Hospital
Garran, Australia, ACT 2605
Royal Brisbane and Womens Hospital
Herston, Australia, 4029
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA - Centre for the North
Prince George, British Columbia, Canada, V2M 7E9
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 6V5
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Ontario
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
London Regional Cancer Program
London, Ontario, Canada, N6A 5W9
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
CHUQ-Pavillon Hotel-Dieu de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Canadian Cancer Trials Group
Trans-Tasman Radiation Oncology Group (TROG)
Investigators
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Study Chair: Arjun Sahgal Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT02512965     History of Changes
Other Study ID Numbers: SC24
First Posted: July 31, 2015    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes