High Dose Radiotherapy for Palliation (Hi-D)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBritish Columbia Cancer Agency
About this trial
Palliative radiation is effective for controlling or preventing symptoms such as pain, bleeding, dyspnea, and cord compression. Recently, studies have shown that additional dose escalation may result in superior local control. The investigators propose a phase II single arm trial to evaluate a novel high-dose radiation regimen, which will be 27 Gray in 3 fractions with dose escalation within the tumour (Hi-D).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older.
Able to provide informed consent
Patient has histologically confirmed solid tumour malignancy
ECOG performance status 0 - 2
Disqualifiers
Hematologic malignancy
Disease limited to intracranial sites
Serious medical co-morbidities precluding radiotherapy
Prior radiation to target lesion that precludes delivery of repeat radiation. All such cases should be discussed with the local and study PIs.
Trial design
Design model
Single group
Treatments tested in this trial
Palliative Radiotherapy
Radiationstandard dose RT
Palliative Radiotherapy
Radiationhigh-dose RT
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: High-Dose RTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Local Control
to determine the length of time from treatment to tumor growth, recurrence, or progression at radiated sites achieved when using high-dose palliative radiotherapy
Time frame
4 years, with 2 years of accrual and 2 years of follow upSecondary outcomes
1
Overall Survival
Time from treatment to death from any cause, or date of last follow-up, whichever occurs first.
Time frame
4 years, with 2 years of accrual and 2 years of follow up.2
Progression-Free Survival
Time from treatment to disease progression at any site or death.
Time frame
4 years, with 2 years of accrual and 2 years of follow up3
Side Effects
determine side effects from the proposed radiotherapy treatment
Time frame
4 years, with 2 years of accrual and 2 years of follow up.4
Local treatment-free survival
Defined as time from treatment to progression beyond next line of local therapy or death from any cause or date of last follow-up, whichever occurs first.
Time frame
4 years, with 2 years of accrual and 2 years of follow upSponsors and contacts
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Source ClinicalTrials.gov
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