5-Day Preoperative Radiation for Soft Tissue Sarcoma
ConditionSoft Tissue Sarcoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically confirmed soft tissue sarcoma of the extremity, trunk or retroperitoneum.
Has been offered preoperative radiation and surgery as part of standard-of-care treatment
Age ≥ 18
KPS ≥ 70 or ECOG 0 to 2
Disqualifiers
History of prior radiation to the area to be treated.
Active use of other anti-cancer investigational agents.
Planned use of concurrent chemotherapy, targeted therapy, or immunotherapy with radiation therapy (defined as the time interval starting 1 week before the first and last fraction of radiation therapy and surgery).
Pregnancy.
Trial design
Design model
Single group
Treatments tested in this trial
External Beam Radiotherapy
RadiationRadiation will be delivered by external beam techniques to the tumor and areas of possible microscopic disease at a dose of 30 Gy divided into 5 equal fractions of 6 Gy (administered over a total of 5 to 10 business day
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: External beam radiotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Post-operative Complication Rate
Rate of post-operative complications.
Time frame
120 days after surgerySecondary outcomes
1
Local Recurrence Rate
Rate of local recurrence, including in-field, borderline and out-field recurrences
Time frame
2 years and 5 years after surgical resectionSponsors and contacts
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Source ClinicalTrials.gov