Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic diagnosis of a soft tissue sarcoma of extremity, pelvis, chest wall or trunk/abdominal wall (non-retroperitoneal location)

ECOG performance status 0-2

Patient must be deemed able to comply with radiation treatment and surgery

Disqualifiers

History of prior radiation to the same area to be irradiated

Pregnancy

Active collagen vascular disease or patients genetically predisposed to increased radiation related side effects

Trial design

Design model

Single group

Treatments tested in this trial

  • Ultra-Hypo-fractionation Radiotherapy

    Radiation

    Five fractions of pre-operative radiation

  • Resection

    Procedure/Surgery

    Surgery

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Moderately-Hypo-fractionation Radiotherapy

    Radiation

    15 fractions of pre-operative radiation

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Group I (UH HRT)Experimental treatment 3 interventions
Group B: Group II (MH HRT)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Local control rate

Will be estimated with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution. The median and a 95% credible interval of the posterior distribution will be reported.

Time frame
Approximately 2 years

Secondary outcomes

1

Complication rate

The complication rate will be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study. The complication rate will also be modeled with a Beta-Binomial model with Beta(0.5, 0.5) as the prior distribution, and it will be monitored continuously throughout the study.

Time frame
Approximately 2 years

Other outcomes

Sponsors and contacts

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