RECRUITING

Total RadIoTherapy of Oligometastatic caNcerS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

Total RadIoTherapy of Oligometastatic caNcerS (TRITONS)

Quick Facts

Study Start:2024-11-12
Study Completion:2034-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06587490

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated informed consent form.
  2. 2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. 3. Age at least 18 years.
  4. 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. 5. Histopathologic confirmation of a solid malignancy.
  6. 6. Newly diagnosed or progressive metastasis (at least 1 and no more than 10 discrete distant metastases visible on staging imaging. At least one metastatic lesion must be outside the brain parenchyma) for which a new line of systemic therapy is started or resumed.
  7. 7. New systemic therapy for metastatic disease initiated no more than 6 months prior to randomization.
  8. 8. 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.
  9. 9. For participants able to cause a pregnancy: use of condoms or other methods to ensure effective contraception with partner during active SABR treatment.
  1. 1. Pregnancy.
  2. 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. 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), or by local institutional radiotherapy dose constraints for safety and efficacy.
  4. 4. Malignant pleural effusion or malignant ascites.
  5. 5. Leptomeningeal disease in the central nervous system.
  6. 6. Metastatic disease in a site where it is not possible to safely treat with SABR to the doses specified in the trial.
  7. 7. Any unresected metastasis \>5 cm in largest diameter or \>3 cm in the brain.

Contacts and Locations

Study Contact

Tyler Seibert, MD, PhD
CONTACT
(858) 822-5354
cancerCTO@health.ucsd.edu
Rana McKay, MD
CONTACT
(858) 822-5354
cancerCTO@health.ucsd.edu

Principal Investigator

Tyler Seibert
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Tyler Seibert, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-12
Study Completion Date2034-11

Study Record Updates

Study Start Date2024-11-12
Study Completion Date2034-11

Terms related to this study

Keywords Provided by Researchers

  • Stereotactic ablative radiotherapy
  • oligometastatic cancer
  • randomized phase III trial
  • biomarkers

Additional Relevant MeSH Terms

  • Oligometastatic Malignant Solid Neoplasm