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Single Dose Radiotherapy (SDRT) in Oligometatstasis Ablation

NCT03543696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-05

No results posted yet for this study

Summary

This study focuses on treatment outcomes of human metastatic cancer which usually fares with dismal (\<5%) survival at 5 years following first diagnosis of a metastasis. However, a subgroup of patients with an initial oligometastatic presentation (i.e. 1-5 clinically detectable lesions) have been reported to respond to complete surgical removal of detectable deposits with up to 20% disease-free survival at 10 years. Patients relapsing with a second oligometastatic presentation respond to a second round of ablation with encouraging rates of 5-year disease free survival. Based on patterns of response to therapy and relapse, we propose investigate on the hypothesis that metastatic disease may be limited in extent, slowly growing and amenable to successive eradication of metastatic deposits. For visible tumor ablation, we propose to employ the effective and safe technique of Single Dose Image-Guided Radiotherapy (SDRT) and to optimize its use in conjunction with systemic therapy. Where SDRT at a full ablative dose (24Gy) is deemed unfeasible, hypofractionated SBRT (9Gy x3) will be offered. Response assessment will be via local control, poly-metastasis-free survival and overall survival rates. Preliminary phase I/II studies indicate remarkable benefits from the SDRT/SBRT in patients with limited metastatic disease. The expected outcomes may be significant conceptual and practical changes in the management of selected metastatic settings resulting in long-term periods of disease-free and overall survival in settings presently associated with dismal prognosis.

Conditions

Interventions

RADIATION

Single Dose Radiotherapy (SDRT)

Sponsors & Collaborators

  • Fundacao Champalimaud

    lead OTHER

Principal Investigators

  • Carlo Greco, MD · Fundacao Champalimaud

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Portugal

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543696 on ClinicalTrials.gov