Soft Tissue Sarcoma of the Extremities Clinical Trial
Official title:
Proton Radiotherapy for Extremity Soft Tissue Sarcoma
This is a study of proton radiotherapy for the pre- or post- operative treatment of patients
with extremity sarcoma. This study will treat patients in two dose groups:
1. patients receiving pre-operative proton therapy and
2. patients receiving post-operative proton therapy. In each dose group, the study is
divided into two phases. In the first phase of the study, the investigators will
determine if treatment with proton therapy is safe and can be delivered on a regular
basis. In the second phase, the investigators will determine if proton therapy has less
long term side effects compared to standard radiation in both pre-operative patients and
post-operative patients.
This study will be performed in two phases. In the first phase, feasibility will be
established using the primary objectives set below. The second part will begin no earlier
than 30 days after the last patient in the initial phase has completed treatment and once
safety and feasibility has been verified.
The primary objective of this study is feasibility. The study will be deemed infeasible if
10% or more of patients experience one of the following:
1. Patient cannot be given treatment because anatomy is such that a dosimetrically
satisfactory treatment plan cannot be devised (95% of planning target volume covered by
95% of the dose).
2. Patient is unable to tolerate more than 25% of treatments (for any reasonable to set
patient up within acceptable limits of tolerance, patient unable to tolerate treatment
position or immobilization for duration of treatment) using proton radiotherapy. Note:
this end-point is proton-therapy specific, and indicates feasibility of proton as
opposed to photon radiotherapy. For example, if the proton-specific patient
immobilization/positioning is not well tolerated or extra time in the treatment position
is too long or uncomfortable, protons delivered per protocol would be deemed not
feasible compared to photons. Any treatments that cannot be delivered with protons will
be delivered using photons, so that the patient receives the prescribed tumor dose.
3. Patient is unable to complete all of his/her treatments within 10 days of estimated date
of treatment completion or requires a treatment break greater than 5 days. Additionally,
no greater than 33% of patients experience a significant toxicity.
Primary Objectives for second phase of study are:
- The primary objective of Phase II in the pre-operative group will be to evaluate the
wound complication rate of pre-operative proton radiotherapy in patients with STS of the
lower extremity.
- The primary objective of Phase II in the post-operative group will be to evaluate the
functional outcome (e.g., fibrosis, joint stiffness, edema) at two years after
post-operative proton radiotherapy in patients with STS of the lower extremity.
Secondary Objectives for both phases of study are:
- To assess the local control rate, progression-free survival and overall survival of
proton radiotherapy for STS of the extremity.
- To determine the acute and late toxicities of proton radiotherapy to the extremities.
- To monitor for effects of proton treatment on tumor and normal tissues using
radiographic imaging (both cohorts) or ex-vivo analysis of tissue samples (pre-operative
cohort only).
- To examine the relationship between pre-treatment hypoxia as determined by F18-EF5
scanning and treatment outcome.
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Status | Clinical Trial | Phase | |
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Recruiting |
NCT05978024 -
Predicting Radiotherapy Response and Toxicities in Soft Tissue Sarcoma of the Extremities - Cohort B
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