A Master Trial Assessing the Technical Feasibility of First-In-Human Real-Time Image Guided Radiation Therapy Methods

ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney

About this trial

The goal of this clinical trial is to determine whether Real-Time Image Guided Radiation Therapy is a feasible method for radiation therapy delivery for patients with cancer.

The main questions it aims to answer are:

* Can all fractions per patient which are intended to be delivered with the real-time IGRT method be completed as planned? * Can the beam accurately hit the tumour in ≥85% of fractions? * Are there any unexpected grade \>3 acute toxicities?

Participants will not require any additional treatments or preparation procedures above those required for normal radiation therapy treatment, to participate in this study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients 18 years or older to be treated with curative radiation therapy

Patients with brain, breast, head and neck, kidney, liver, lung, pancreas, prostate or spine cancer

ECOG performance status 0-2

Ability to understand and the willingness to sign a written informed consent document

Disqualifiers

Pregnancy,

Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements or severe psychiatric illness/social situation

Additional inclusion and exclusion criteria may apply to a specific sub-study

Trial design

Design model

Single group

Treatments tested in this trial

  • Real-Time Image Guided Radio Therapy (IGRT)

    Device

    Real-time image guided radiation therapy (IGRT) methods image the cancerous tumour in real-time, enabling the treatment beam to focus its destructive energy on the patient's cancer, not their healthy tissue.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Real-Time IGRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful application of Real-Time IGRT

Each real-time IGRT method under study is deemed feasible if successfully applied in 18 out of 20 consecutive patients (success rate of 90%), with a maximum of 40 patients to be included per cohort. If the real-time IGRT method is unsuccessfully applied in three consecutive patients or the real-time IGRT method is not successfully applied in 18 out of 20 consecutive patients after the inclusion of 40 patients, it is considered unfeasible. For each real-time IGRT method, success is defined by three general criteria (each of the three criteria should be met to reach feasibility): 1. All fractions per patient which are intended to be delivered with the real-time IGRT method are completed as planned 2. Absence of geographical miss in ≥85% of fractions or, in case of stereotactic treatments, in all minus one fraction. Geographical miss is defined as the clinical treatment volume outside the treated volume as measured on post-treatment image analysis 3. No unexpected grade \>3 acute toxicities

Time frame
From the date of enrolment until 90 days after the completion of radiotherapy treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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

University of Sydney

Lead sponsor

Medical Research Future Fund

Collaborator

This trial is not recruiting at the moment. You can still explore other options: