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New treatment option for Sarcoma,Soft Tissue
Official title Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
ClinicalTrials.gov ID: NCT04219202
What this study is testing
- What it's testing
- The study is a randomized, open, prospective phase II study. The aim of the study is to evaluate the safety and feasibility of a hypofractionated, accelerated radiation approach based on the incidence of grade 3-5 NCI Common Terminology Criteria for Adverse Events (NCI-CTC-AE ) toxicity and / or termination of the planned therapy for any reason with neoadjuvant radiation with active beam guidance of the retroperitoneal Sarcomas using protons or carbon ions before a subsequent tumor resection.
- 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
Ages 18 and older
You may be able to join if
- Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable
- Karnofsky index of ≥ 70%
- Age from 18 years
- Completed patient information and written consent
- ability to give consent
You likely can't join if
- Stage IV (distant metastases)
- Lymphogenic metastasis
- Metal implants at the level of the sarcoma, which influence the treatment planning
- Previous radiation therapy in the treatment area
- Desmoid tumors, peritoneal sarcomatosis, GIST
- Simultaneous participation in another clinical study that could influence the results of the respective study
See the full eligibility criteria
- Histologically confirmed retroperitoneal soft-tissue sarcoma which is resectable or marginally resectable
- Karnofsky index of ≥ 70%
- Age from 18 years
- Completed patient information and written consent
- ability to give consent
- Stage IV (distant metastases)
- Lymphogenic metastasis
- Metal implants at the level of the sarcoma, which influence the treatment planning
- Previous radiation therapy in the treatment area
- Desmoid tumors, peritoneal sarcomatosis, GIST
- Simultaneous participation in another clinical study that could influence the results of the respective study
- Active medical implants for which there is no license for ion irradiation at the time of treatment (e.g. pacemaker, defibrillator)
- Pregnant women
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Germany
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Germany. 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.