Total RadIoTherapy of Oligometastatic caNcerS

Description

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 SABR 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.

Conditions

Oligometastatic Malignant Solid Neoplasm

Study Overview

Study Details

Study overview

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 SABR 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.

Total RadIoTherapy of Oligometastatic caNcerS (TRITONS)

Total RadIoTherapy of Oligometastatic caNcerS

Condition
Oligometastatic Malignant Solid Neoplasm
Intervention / Treatment

-

Contacts and Locations

La Jolla

University of California San Diego, La Jolla, California, United States, 92093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Provision of signed and dated informed consent form
  • 2. Stated willingness to comply with all study procedures and availability for the duration of the study
  • 3. Persons, aged at least 18 years
  • 4. Deemed eligible to undergo standard systemic therapy and SABR to metastatic sites (i.e., patient has adequate health and life expectancy, and treatment is not contraindicated)
  • 5. Histopathologic confirmation of a solid malignancy
  • 6. At least one and no more than ten discrete distant metastases visible on staging imaging. At least one metastatic lesion must be outside the brain parenchyma.
  • 7. For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during active SABR treatment.
  • 8. For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during active SABR treatment.
  • 1. Pregnancy
  • 2. Contraindications to radiotherapy, including interstitial lung disease if thoracic radiation is planned; Crohn's disease if the gastrointestinal tract will receive radiotherapy; active connective tissue disorders such as scleroderma or uncontrolled lupus; moderate or severe liver dysfunction (Child Pugh B or C) if the patient has liver metastases.
  • 3. Prior radiation therapy to an area requiring treatment in the present study, if the composite dose would exceed normal tissue constraints specified by UC San Diego radiotherapy Standards and Guidelines (published by the Department of Radiation Medicine and Applied Sciences).
  • 4. Malignant pleural effusion or malignant ascites.
  • 5. Leptomeningeal disease in the central nervous system.
  • 6. Metastatic disease in a site where it is not possible to safely treat with SABR to the doses specified in the trial.
  • 7. Any unresected metastasis \>5 cm in largest diameter or \>3 cm in the brain.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tyler Seibert,

Tyler Seibert, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

2032-08