Hypofractionated Radiotherapy for Soft Tissue Sarcomas

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-11

Study Completion Date

2027-12-31

Brief Summary

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One of the main challenges in treating sarcomas with radiation is the toxicity to normal structures around the sarcoma. Early reports suggest Hypofractionated Radiotherapy will be safe and effective for treatment of soft tissue sarcomas. However, given the rarity of this disease, the diversity of histological sub-types, and the variety of locations where these can occur (anywhere in the body), more data is needed to provide understanding of the safety and efficacy of hypofractionated radiotherapy for treatment of this disease. The hypothesis is that by using hypofractionated radiotherapy, highly conformal high dose radiation can be delivered to soft tissue sarcomas, while respecting established normal tissue constraints and that local control rates will be greater than historical rates reported with conventional fractionation.

Eligible participants with biopsy proven soft tissue sarcoma will be on study for up to 60 months.

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Detailed Description

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Conditions

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Soft Tissue Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypofractionated Radiotherapy for Soft Tissue Sarcoma

Participants will be treated with 3-8 fractions, with the maximum prescribed dose to the Planning Tumor Volume (PTV) volume being 60 Gy delivered over a period of at most 8 weeks.

Group Type EXPERIMENTAL

Hypofractionated Radiotherapy

Intervention Type RADIATION

Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.

Interventions

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Hypofractionated Radiotherapy

Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Biopsy proven soft tissue sarcoma, either localized and inoperable/unresectable or metastatic, that is deemed by the treating physician to be targetable with hypofractionated radiotherapy.
* Participant refuses surgery or is aware that surgery is not recommended for them
* Karnofsky performance status \> 60
* Able to understand and sign an informed consent form

Exclusion Criteria

* Pregnant
* Chemotherapy or systemic anti-cancer treatment within the preceding two weeks
* Unable to undergo imaging or positioning necessary for radiotherapy planning
* Prior radiation therapy in the field that, at the discretion of the treating physician, prevents safe delivery of hypofractionated radiotherapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No