Neoadjuvant Irradiation of Retroperitoneal Soft Tissue Sarcoma With Ions Retro-Ion
ConditionSarcoma,Soft Tissue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital Heidelberg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Proton radiation
RadiationTherapeutic radiation Treatment with Protons
Carbon Ion radiation
RadiationTherapeutic radiation Treatment with Carbon Ions
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Proton TreatmentActive comparator 1 intervention
Group B: Carbon Ion TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of grad 3-5 NCI-CTC-AE toxicities
Evidence of the safety and practicability of the study treatment assessed for the incidence of grade 3-5 NCI-CTC-AE toxicity and / or termination of the planned therapy for any reason
Time frame
within 12 month after radiation treatmentSecondary outcomes
1
local Tumor control
Number of patients without new arising Tumors at the treated Tumor site
Time frame
within 12 month after radiation treatment2
local Progression free survival
Number of patients without local Progression at the treated tumor site
Time frame
within 12 month after radiation treatment3
disease free survival
Number of Patients without relapse of treated disease
Time frame
within 12 month after radiation treatment4
Overall survival
Assesment of alive patients
Time frame
within 12 month after radiation treatmentSponsors and contacts
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Source ClinicalTrials.gov