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

NCT02512965 | Completed Results DMC

• 1 other identifier: SC24
• Study Type: interventional
• Target: 229
• Locations: 2 countries
• Sites: 22

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.

Conditions

Spinal Metastases

Outcome Measures

Primary Outcomes (1)

• Phase III: Complete Pain Response at 3 Months Post-radiation

  A Complete Pain Response is defined as a pain score of zero (0) at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalent) .

  3 months

Secondary Outcomes (3)

• Complete Pain Response at 6 Months Post Radiation Based on the International Bone Metastases Consensus Working Party Criteria

  6 months post radiation

• Radiation Site Progression-free Survival Rate at 6 Months Using MRI Imaging

  6 months.

• Overall Survival Rate at 6 Months

  6 months post radiation

Study Arms (2)

Standard Conventional Radiotherapy

ACTIVE COMPARATOR

Standard Conventional Radiotherapy (CRT) 20 Gy in 5 fractions

Radiation: 20 Gy in 5 fractions

Stereotactic Body Radiotherapy

EXPERIMENTAL

Stereotactic Body Radiotherapy (SBRT) 24 Gy in 2 fractions

Radiation: Conventional SBRT: 24 Gy in 2 fractions

Interventions

20 Gy in 5 fractions RADIATION

Standard Conventional Radiotherapy

Conventional SBRT: 24 Gy in 2 fractions RADIATION

Stereotactic Body Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Trans Tasman Radiation Oncology Group: collaborator

Study Sites (22)

Auckland City Hospital

Grafton, Aucklund, 1023, Australia

Location

Liverpool Cancer Therapy Centre, Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Princess Alexandra Hospital

Brisbane, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter McCallum Cancer Institute

Melbourne, Victoria, 3002, Australia

Location

Peter Mac - Sunshine Hospital

St Albans, Victoria, 3021, Australia

Location

Canberra Hospital

Garran, ACT 2605, Australia

Location

Royal Brisbane and Womens Hospital

Herston, 4029, Australia

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Centre for the North

Prince George, British Columbia, V2M 7E9, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, V8R 6V5, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (2)

• Sahgal A, Myrehaug SD, Siva S, Masucci GL, Maralani PJ, Brundage M, Butler J, Chow E, Fehlings MG, Foote M, Gabos Z, Greenspoon J, Kerba M, Lee Y, Liu M, Liu SK, Thibault I, Wong RK, Hum M, Ding K, Parulekar WR; trial investigators. Stereotactic body radiotherapy versus conventional external beam radiotherapy in patients with painful spinal metastases: an open-label, multicentre, randomised, controlled, phase 2/3 trial. Lancet Oncol. 2021 Jul;22(7):1023-1033. doi: 10.1016/S1470-2045(21)00196-0. Epub 2021 Jun 11.

  PMID: 34126044 RESULT

• Tseng CL, Soliman H, Myrehaug S, Lee YK, Ruschin M, Atenafu EG, Campbell M, Maralani P, Yang V, Yee A, Sahgal A. Imaging-Based Outcomes for 24 Gy in 2 Daily Fractions for Patients with de Novo Spinal Metastases Treated With Spine Stereotactic Body Radiation Therapy (SBRT). Int J Radiat Oncol Biol Phys. 2018 Nov 1;102(3):499-507. doi: 10.1016/j.ijrobp.2018.06.047. Epub 2018 Jul 10.

  PMID: 30003994 DERIVED

Results Point of Contact

• Title: Dr. Keyue Ding
• Organization: Canadian Cancer Trials Group

kding@ctg.queensu.ca

16135336430

Study Officials

• Arjun Sahgal

  Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 31, 2015
• Study Start: January 4, 2016
• Primary Completion: July 21, 2020
• Study Completion: August 16, 2021
• Last Updated: February 13, 2024
• Results First Posted: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (8); CA (14)