Total RadIoTherapy of Oligometastatic caNcerS

Conditions

• Oligometastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• stereotactic ablative radiotherapy — RADIATION
  Stereotactic ablative radiotherapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organs.

Study Details

This is a Phase III non-blinded randomized study evaluating patients with oligometastatic cancers (up to 10 metastases). Subjects are randomized 1:1 to stereotactic ablative radiotherapy (SABR) plus standard of care therapies versus standard of care therapies alone. The investigators will measure progression-free survival at 2 years based on the hypothesis that subjects treated with SABR plus standard of care will not experience disease progression for a longer period of time than subjects treated with standard of care alone. The investigators will also measure overall survival and safety of SABR, as well as biomarkers that may help predict, in the future, who will benefit from the SABR treatment.

Key Dates

Start date

Nov 12, 2024

Status verified

Oct 2025

Primary completion

Nov 30, 2033

Completion

Nov 30, 2034

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: SABR+SOC
  stereotactic ablative radiotherapy (SABR) plus standard of care (SOC) cancer therapy
• No Intervention: SOC
  standard of care (SOC) cancer therapy

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: 2 years ]

Central Contacts

• Tyler Seibert, MD, PhD
  (858) 822-5354
  [email protected]
• Rana McKay, MD
  (858) 822-5354
  [email protected]

Locations (1)

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