NCT04085029

Brief Summary

The purpose of this study is to provide a registry of participants in order to assess the acute adverse event rates following ablative radiotherapy for metastatic disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
40mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Sep 2019Sep 2029

First Submitted

Initial submission to the registry

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

September 26, 2019

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

9.9 years

First QC Date

September 9, 2019

Last Update Submit

February 3, 2026

Conditions

OligometastasisMetastatic Cancer

Keywords

Ablative radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Occurrence of acute adverse events following radiotherapy

    90 Days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at Duke University Health System Radiation Oncology treatment facilities or Durham VA Medical Center

You may qualify if:

  • Age ≥ 18 years of age
  • Radiographic evidence of metastatic disease (may include oligoprogression, oligorecurrence or oligometastasis) at the time of study enrollment
  • Planned to receive, currently receiving, or have completed hypofractionated image guided radiotherapy (ablative radiotherapy) to an extracranial site(s)
  • Patient must sign study-specific informed consent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Duke Cancer Institute Cary

Cary, North Carolina, 27518, United States

RECRUITING

Durham Veterans Administration Health Care System (DVAHCS)

Durham, North Carolina, 27705, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Duke Women's Cancer Care Raleigh

Raleigh, North Carolina, 27607, United States

RECRUITING

Duke Raleigh Hospital

Raleigh, North Carolina, 27609, United States

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Joseph Salama, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Office

CONTACT

(919) 668 3726RadOnc-Clinical_Trials@dm.duke.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

September 26, 2019

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2029

Last Updated

February 5, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)