Adaptive Radiotherapy for Cancer

(ART-Hypo Trial)

MP
EE
Overseen ByEva Eva Nkurunziza
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiotherapy to individuals with certain cancers, such as prostate or cervical cancer. The focus is on adaptive hypofractionated radiotherapy, which adjusts treatment based on daily imaging to minimize unnecessary radiation to surrounding organs. Researchers aim to determine if this method causes fewer side effects than standard-of-care radiotherapy while maintaining effectiveness. Suitable candidates are those already enrolled in a specific cancer registry and who have consented to be contacted for new trials. The goal is to ensure the new treatment is as safe and effective as traditional methods. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adaptive hypofractionated radiotherapy (ART) is generally well-tolerated by patients. One study found that this method for prostate cancer carries a low risk of severe side effects. Another study demonstrated that hypofractionated radiotherapy, which involves fewer but stronger doses of radiation, is safe for treating certain oral cancers when combined with good supportive care. Additionally, ART for bladder cancer reduces treatment-related side effects. These findings suggest that ART could safely deliver targeted radiation while minimizing harm to nearby healthy tissues.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Adaptive Hypofractionated Radiotherapy (ART-Hypo) because it offers a tailored approach to cancer treatment that adapts to changes in the tumor and surrounding tissue over time. Unlike the standard-of-care radiotherapy, which delivers a consistent dose across sessions, ART-Hypo uses advanced imaging and software to adjust the radiation dose and target area, potentially enhancing effectiveness and minimizing damage to healthy tissue. This could lead to fewer side effects and improved outcomes for patients, making it a promising development in cancer care.

What evidence suggests that this trial's treatments could be effective for cancer?

This trial will compare Adaptive Hypofractionated Radiotherapy (ART-Hypo) with Standard-of-care Radiotherapy. Research has shown that ART can effectively treat cancer while reducing side effects. This radiation therapy uses fewer but stronger doses, which helps control cancer and remains safe for patients. For example, one study found that a weekly treatment plan with very strong doses worked well and was safe for older patients. Another study showed that ART with high-dose radiation achieved high success rates and fewer side effects, particularly for cervical cancer. Overall, ART precisely targets tumors and limits radiation to nearby healthy tissues, making it a promising option for certain cancers.678910

Who Is on the Research Team?

MB

Maroie Barkati, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for adults with pelvic cancers like prostate, endometrial, cervical, or rectal cancer who are enrolled in a specific registry and have agreed to be contacted for research. People with certain metal implants or MRI restrictions can't join if they have intact prostate cancer.

Inclusion Criteria

Enrolled in PERa registry (CHUM CER 17.0.32), consented to contact for investigational trials, consented to serve as control, and randomly selected to be offered the experimental intervention.

Exclusion Criteria

For intact prostate stratum: Contraindications to MRI (e.g., pacemaker, potentially mobile metal implant, claustrophobia).
For intact prostate stratum: Hip replacement, or other pelvic metalwork which causes significant artefact on MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard-of-care radiotherapy or hypofractionated adaptive radiotherapy

Up to 4 weeks
Daily visits for radiotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Regular follow-up visits as per protocol

Long-term follow-up

Monitoring of oncologic outcomes and patient-reported outcomes

12 to 24 months

What Are the Treatments Tested in This Trial?

Interventions

  • Adaptive Hypofractionated Radiotherapy
  • Standard-of-care Radiotherapy

Trial Overview

The study compares two types of radiation therapy: standard treatment versus a newer method called adaptive hypofractionated radiotherapy that uses daily imaging to adjust the plan. Participants are randomly assigned to one group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Adaptive Hypofractionated Radiotherapy (ART-Hypo)Experimental Treatment1 Intervention
Group II: Standard-of-care RadiotherapyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Citations

Clinical Outcomes of Image Guided Adaptive ... - PMC

There is good evidence that symptomatic local disease can be relieved for the duration of survival with hypofractionated radiation therapy (21 Gy in 3 fractions ...

Clinical Outcomes of a Randomized Trial of Adaptive Plan ...

Weekly ultrahypofractionated 36 Gy/6 fraction radiation therapy is safe and provides good local control rates in this older patient population. Introduction.

107 Moderated Hypofractionated Online Adaptive ...

Moderated hypofractionated oART with HDR brachytherapy appears to be a very promising treatment in LACC, leading to high response rates and limited side effects ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33316362/

Clinical Outcomes of a Randomized Trial of Adaptive Plan- ...

Weekly ultrahypofractionated 36 Gy/6 fraction radiation therapy is safe and provides good local control rates in this older patient population.

DEHART: Dose-Escalated Hypofractionated Adaptive ...

Radiation dose escalation with hypofractionation has shown unparalleled local control in many other malignancies, such as non-small cell lung cancer, but has ...

Impact of Adaptive Radiation Therapy on Toxicity in Prostate ...

Magnetic resonance image-guided adaptive stereotactic body radiotherapy for prostate cancer: Preliminary results of outcome and toxicity. Br ...

A phase I/II study evaluating the feasibility and safety of ...

Moderately hypofractionated radiotherapy is well tolerated and can safely be delivered for resected oral cavity tumors with optimal supportive care.

Moderated Hypofractionated Online Adaptive ...

A total of 26 patients have completed treatment with moderated hypofractionated oART and HDR brachytherapy. All patients (100%) had a clinical complete response ...

Safety and Tolerability of Online Adaptive High-Field ...

The findings of this study suggest that online adaptive MR-guided radiotherapy is associated with a low risk of high-grade acute toxic effects.

Hypofractionated Radiation Therapy — A Dark Side

There Simply Isn't Enough Long-Term Data Available for Cyberknife and Other Hypofractionated Therapy to Prove There Have any Better Results Than Current Options.