All studies
Active not recruitingPHASE3INTERVENTIONAL

Stereotactic Ablative Radiotherapy for Comprehensive Treatment of 4-10 Oligometastatic Tumors

This research is for people who have cancer that has spread to a few (4 to 10) small areas in their body, but isn't widespread. Doctors are trying to find the best way to treat these 'oligometastatic' cancers. This study will compare a focused radiation treatment called Stereotactic Ablative Radiotherapy (SABR) with standard treatments like chemotherapy or hormone therapy. The main goal is to see if SABR helps people live longer, stops the cancer from growing for longer, and improves their overall quality of life. We want to understand if treating all these small cancer spots with SABR is better than current approaches for people in this situation.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
David Palma
Enrolment target
204
Start
22 Feb 2019
Estimated completion
01 Jan 2029

What is this study about?

This study is particularly for people who have cancer that has spread, but only to a limited number of new places – specifically, between 4 and 10 small spots in their body. Doctors call this 'oligometastatic disease'. If your cancer has spread widely throughout your body, this study would not be suitable.

The main idea behind this study is to explore if a special type of very focused radiation treatment, called Stereotactic Ablative Radiotherapy (SABR), can be more effective than standard care for these types of cancers. SABR uses high doses of radiation delivered very precisely to destroy cancer cells, while trying to protect surrounding healthy tissues. We want to find out if treating all these small cancer spots with SABR helps people live longer, keeps the cancer from growing for a longer time, and improves their general well-being, compared to current common treatments like chemotherapy, hormone therapy, or even just keeping a close watch.

This is important because currently, it's not fully clear whether treating all these scattered cancer spots with SABR is the best approach for everyone with 4 to 10 metastatic lesions. By carefully comparing SABR with regular treatments, this study hopes to provide clear answers that could change how we treat people in the future and give them the best possible care.

Key takeaways

  • Study for cancer that has spread to 4-10 small spots.
  • Compares special radiation (SABR) to usual treatments.
  • Aims to see if SABR helps people live longer and better.
  • Participation involves random assignment to a treatment group.
  • You can leave the study at any time.

Who may be eligible?

To join this study, you need to be 18 years or older and generally well enough to take part in daily activities. Doctors will check if your main cancer area is under control and that you have between 4 and 10 small areas where the cancer has spread. All these small cancer spots must be in places that can be safely treated with the special radiation.

You wouldn't be able to join if you have serious health problems that might make radiation treatment unsafe, such as certain lung or gut conditions. Also, if you have a very large single cancer spot (over 5 cm) or significant spread to certain areas like the brainstem or extensive brain involvement, you wouldn't be suitable. Women who are pregnant or breastfeeding also cannot participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Has your main cancer gotten under control?
  3. Do you have between 4 and 10 small areas of cancer spread?
  4. Are you generally well enough for daily activities?
  5. Are you comfortable with the specific spots being treated by radiation and you don't have major health conditions that would make radiation unsafe?
  6. Are you not pregnant or breastfeeding?
Answer every question to see your result.

What does participation involve?

This study is a 'Phase 3' trial, which means it's comparing a new approach (SABR) with standard treatments to see which is better. You would be randomly assigned to either receive SABR or continue with standard treatments like chemotherapy, immunotherapy, hormone therapy, or watchful waiting, as decided by your doctors. The specific duration of your treatment and follow-up would depend on which group you are in and your individual treatment plan. You would have regular check-ups, scans, and discussions with the study team to monitor your progress and well-being. The total duration of follow-up for the study will likely be several years to assess long-term outcomes, but the most intensive parts involving active treatment would be shorter.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from a treatment that proves more effective than current approaches, potentially helping you live longer or improving your quality of life. However, there's no guarantee of personal benefit, and the treatments, including SABR or standard care, can have side effects. These side effects would be carefully explained to you by the medical team. You also have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Alfred Health
    Verified postcode
    Melbourne, Australia
  • BC Cancer Agency, Vancouver Island Centre
    Verified postcode
    Victoria, Canada
  • Nova Scotia Health Authortiy
    Verified postcode
    Halifax, Canada
  • Health Sciences North
    Verified postcode
    Greater Sudbury, Canada
  • Grand River Hospital
    Verified postcode
    Kitchener, Canada
  • London Regional Cancer Program of the Lawson Health Research Institute
    Verified postcode
    London, Canada
  • Trillium Health Partners-Credit Valley Hospital
    Verified postcode
    Mississauga, Canada
  • Niagra Health System
    Verified postcode
    St. Catharines, Canada
  • University Health Network
    Verified postcode
    Toronto, Canada
  • Centre hospitalier de l'Université de Montréal-CHUM
    Verified postcode
    Montreal, Canada
  • VU University Medical Centre
    Verified postcode
    Amsterdam, Netherlands
  • University Hospital of Zürich
    Verified postcode
    Zurich, Switzerland

Common questions

What does 'oligometastatic' mean?

It means your cancer has spread, but only to a limited number of spots (in this study, 4 to 10 spots), and isn't widespread throughout your body.

What is SABR?

SABR (Stereotactic Ablative Radiotherapy) is a highly precise radiation treatment that delivers strong doses of radiation directly to cancer spots, while trying to protect healthy areas nearby.

Will I get to choose my treatment?

No, you'll be randomly assigned to either the SABR group or the standard treatment group, like drawing lots. This helps ensure fair comparison.

What happens if I want to leave the study?

You can leave the study at any time, for any reason, and it won't affect your ongoing medical care.

What are 'standard treatments'?

These are the usual and accepted ways doctors treat cancer, such as chemotherapy, immunotherapy, hormone therapy, or sometimes just closely watching the cancer.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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