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New treatment option for Soft Tissue Sarcoma (STS)
Official title Dose-escalated, Hypofractionated, Definitive Proton Radiotherapy for Patients With Inoperable Soft Tissue Sarcoma.
ClinicalTrials.gov ID: NCT07173972
What this study is testing
- What it's testing
- The purpose of the study is to study if dose escalated proton radiotherapy can improve local controll for patients with inoperable soft tissue sarcomas. The standard treatment is photon-based radiation.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 18 years of age at the time of informed consent.
- Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- For patients with metastatic disease a life-expectancy greater than 2 years should be expected.
You likely can't join if
- Patients with a prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or how well...
- Previous radiotherapy to the tumor site.
- Patients with pacemakers and/or implanted defibrillators.
- Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.
- Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of...
See the full eligibility criteria
- ≥ 18 years of age at the time of informed consent.
- Histological diagnosis of soft tissue sarcoma including gastrointestinal stromal tumor (GIST).
- Measurable disease according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
- For patients with metastatic disease a life-expectancy greater than 2 years should be expected.
- Before patient registration, written informed consent must be given according to national and local regulations.
- Ability to fill in patient questionnaires and comply with study procedures, including travelling to Bergen or Oslo for Proton Beam radiotherapy.
- Patients with a prior or concurrent malignant disease whose natural history or treatment have the potential to interfere with the safety or how well it works assessment of this clinical trial are not eligible. Patients...
- Previous radiotherapy to the tumor site.
- Patients with pacemakers and/or implanted defibrillators.
- Patients not able to give an informed consent or comply with study regulations as deemed by study investigator.
- Administration of systemic cancer therapy (i.e. chemotherapy, targeted therapy or immune therapy) within 14 days prior to the first fraction of radiotherapy.
The study team makes the final eligibility decision.
Where it's taking place
- Bergen, Norway
- Oslo, Norway
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 study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bergen, Norway; Oslo, Norway. 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.