Recruiting NA Breast Cancer

Compares treatment options for Breast Cancer

Official title OligoCare TwiCs (Trials Within Cohorts) Trial Comparing Acute Toxicity in Single-fraction vs Multiple-fraction SBRT for Metastasis-directed Treatment (SPRINT)

ClinicalTrials.gov ID: NCT06462963

What this study is testing

What it's testing
The goal of this clinical trial is to evaluate single-fraction metastases-directed SBRT in the broader radiation oncology community and to compare its safety and efficacy profile with the current Standard of Care (SoC) of multiple-fraction SBRT in patients with oligometastatic disease of primary breast, prostate, NSCLC and colorectal cancer having all lesions that will be treated with radical radiotherapy amenable to single-fraction SBRT. The main question/hypothesis this clinical trial aims to answer is: \- Single-fraction SBRT has comparable outcomes as those obtained with multiple fraction SBRT, both in terms of safety and efficacy.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Adults

You may be able to join if

  • Patient is part of the RP1822-OligoCare. As in OligoCare, ALL active cancer lesions (loco-regional primary and all oligometastases) were or will be...
  • All lesions that will be treated with radical radiotherapy have to be amenable to single-fraction SBRT. Concurrent systemic treatment is allowed.
  • Written informed consent must be given according to ICH/GCP, and national/local regulations. Patients will be consented in a step-wise approach. Step...

You likely can't join if

  • All targeted lesion judged by the treating physician to be associated with risks for severe toxicity following single-fraction SBRT. The following...
  • Pulmonary metastases within 1 cm of proximal bronchial tree, esophagus or brachial plexus
  • Metastases within \< 5 mm of any hollow GI structure: esophagus, stomach, small bowel, large bowel
  • Metastases within \< 5 mm of the spinal cord, the cauda equina or the brachial plexus
  • Metastases \> 5 cm in largest diameter.

The study team makes the final eligibility decision.

Where it's taking place

  • Aalst, Belgium
  • Brussels, Belgium
  • Ghent, Belgium
  • Kortrijk, Belgium
  • Wilrijk, Belgium
  • Florence, Italy
  • Milan, Italy
  • Negrar, Italy
  • Roma, Italy
  • Torino, Italy
  • Deventer, Netherlands
  • Nijmegen, Netherlands
  • Bern, Switzerland
  • Zurich, Switzerland

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Aalst, Belgium; Brussels, Belgium; Ghent, Belgium; Kortrijk, Belgium; Wilrijk, Belgium; Florence, Italy and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.