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Early Radiotherapy Versus Observation for High-risk Asymptomatic or Minimally Symptomatic Bone Metastases

ConditionsSolid NeoplasmsBone MetastasesAsymptomatic or Minimally SymptomaticHigh Risk for Skeletal Events
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Research Antwerp

About this trial

The goal of this clinical trial is to learn whether radiotherapy (i.e. treatment with ionizing radiation to destroy cancer cells) can prevent symptoms in patients with metastatic cancer, having high-risk bone metastases that currently result in no or only mild symptoms. High-risk bone metastases are bone metastases at high-risk of developing bone complications, such as fractures or myelum compression.

The main questions this study aims to answer are:

* Can preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases (and observation or medication) decrease the number of skeletal related events (i.e. bone complications due to bone metastases) in patients with metastatic cancer? * Can preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases (and observation or medication) decrease the need for hospitalization related to such bone metastases, improve overall survival and (health-related) quality of life? * What are the side effects of preventive radiation of high-risk asymptomatic or minimally symptomatic bone metastases?

Researchers will compare 2 treatment groups in order to answer the questions listed above: 1 group treated with medication or observation alone (group A) and 1 group treated with medication or observation and preventive radiotherapy (group B).

Participants will

* be screened to assess whether they are eligible to participate in the study. * be randomized (i.e. drawn) into the 2 treatment groups mentioned above. * be treated with preventive radiotherapy if they were drawn in treatment group B. * need to attend follow-up visits (may be via teleconsultation) at 1, 3, 6, 12, 18 and 24 months after date of randomization during which safety and efficacy is monitored. During these follow-up visits, the general health condition of the participant is evaluated, the occurrence of any bone complication, the medications taken by the participant are registered, the degree of pain and location of the high-risk bone metastases are determined and possible side effects are registered. Furthermore, the participant needs to complete 2 questionnaires at each visit regarding his/her quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

I1: Histologically confirmed solid tumor malignancy (with polymetastastic spread (≥ 3 metastases))

I3: Number of Risk Factors (NRF) prognostic score 0-2

I4: Age ≥ 18 years

I5: Ability to provide informed consent (either by the patient or by a legally authorized representative)

Disqualifiers

E1: Previous RT to the target treatment site(s)

E2: NRF prognostic score 3

E3: Serious medical co-morbidities that preclude radiotherapy

E4: Bone lesion complicated with a pathological fracture or impending pathologic fracture for which prophylactic stabilization is recommended, characterized by Mirels score of ≥9 [Mirels et al].

Trial design

Design model

Parallel

Treatments tested in this trial

  • Preventive radiotherapy

    Radiation

    Either conventional radiotherapy (single dose of 8 Gy) or Stereotactic Ablative Body Radiation (either 1x20 Gy, 2x12 Gy, 3x10 Gy or 5x8 Gy) will be delivered depending on the participant's prognostic outcome.

  • Systemic therapy (Standard of Care)/Observation

    Drug

    It concerns systemic therapy if applicable according to the standard of care or only observation.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm A: observational armActive comparator 1 intervention
Group B: Arm B: upfront radiotherapy armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Time to a symptomatic skeletal related event (SSE) in any bone metastasis or death due to any cause whichever occurs first

Time to an SSE in any bone metastasis or death due to any cause whichever occurs first. An exception are SSE in bone metastases that were already treated with surgery or radiotherapy before study participation.

Time frame
Measured from the date of randomization to the date when an SSE occurs in any bone metastasis, date of death due to any cause or last follow-up visit at 24 months after randomization whichever occurs first.

Secondary outcomes

1

Need for hospitalization related to the high-risk bone metastasis(es).

The number of hospitalizations related to the high-risk bone metastases will be compared between arm A (systemic therapy/observation) and arm B (systemic therapy/observation + upfront radiotherapy).

Time frame
Measured from date of study randomization to last follow-up visit (24 months after randomization date), date of death of any cause or early end of participation in the study due to other reasons whichever occurs first.
2

Overall survival (OS)

Overall survival

Time frame
Measured from time of study randomization to date of death of any cause or last follow-up visit (24 months after randomization date) whichever occurs first
3

Quality of life (QoL) measurement by EORTC QLQ-C15-PAL questionnaire (physical and emotional function, dyspnoea, pain, sleeping difficulties, appetite, nausea/vomiting, constipation, fatigue)

Changes in the scores regarding physical and emotional function, dyspnoea, pain, sleeping difficulties, appetite, nausea/vomiting, constipation and fatigue over time compared to baseline as well as absolute scores will be compared between both treatment arms. The scale ranges from 1 up to 4 with a higher score representing a worse outcome.

Time frame
From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.
4

Quality of life (QoL) measurement by EORTC QLQ-C15-PAL questionnaire (overall quality of life)

Changes in the scores, representing the participant's overall quality of life, over time compared to baseline as well as absolute scores will be compared between both treatment arms. The scale ranges from 1 up to 7 with a higher score representing a better outcome.

Time frame
From screening until last follow-up visit (24 months after randomization date), date of death of any cause, early end of study participation due to other reason or unscheduled follow-up visit at 1 week after occurrence of an SSE whichever occurs first.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Research Antwerp

Lead sponsor

Kom Op Tegen Kanker

Collaborator

Source ClinicalTrials.gov
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