Experimental arm for Neoplasm Metastasis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Neoplasm Metastasis+7 More
Experimental arm - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether it is better to give standard care or stereotactic ablative radiotherapy to people with metastatic head and neck cancer who have 1-5 new extracranial tumors.

Eligible Conditions
  • Neoplasm Metastasis
  • Metastatic Cancers
  • Oligoprogressive
  • Head and Neck Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 5 years

5 years
Grade ≥ 3 toxicity Measured using the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Local control
Overall survival
Progression free survival
Quality of life Measured using the FACT-G tool, head and neck cancer-related patient reported outcome- CTCAE (PRO-CTCAE) and Quality of life 5-level EQ-5D
Time to next systemic therapy

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Standard of care
1 of 2
Experimental SABR arm
1 of 2

Active Control

Experimental Treatment

46 Total Participants · 2 Treatment Groups

Primary Treatment: Experimental arm · No Placebo Group · Phase 2

Experimental SABR arm
Radiation
Experimental Group · 1 Intervention: Experimental arm · Intervention Types: Radiation
Standard of care
Other
ActiveComparator Group · 1 Intervention: Standard arm · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Experimental arm
2010
N/A
~110

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
323 Previous Clinical Trials
111,849 Total Patients Enrolled
3 Trials studying Neoplasm Metastasis
149 Patients Enrolled for Neoplasm Metastasis

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have metastatic HNSCC, with pathological or radiological proof of metastasis.
You have a history of progressive disease while on systemic treatment (any line).
You have a performance status of 0-2.
You have 5 or more extracranial lesions ≤ 5 cm and involving ≤ 3 organs
You have a site of disease that can be safely treated and targetable with SABR.
Patients with prior metastases that have been treated with ablative therapies (e.g

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: November 13th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.