NCT03543696

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2011

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

8.1 years

First QC Date

February 16, 2018

Last Update Submit

May 2, 2026

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Efficacy of SDRT ablation

    Efficacy of Single Dose Radiotherapy (SDRT 24Gy) of metastatic lesions measured by PERCIST criteria with repeated PET-CT studies.

    24 months

Secondary Outcomes (1)

  • Progression-free survival

    24 months

Study Arms (1)

Single Dose Radiotherapy (SDRT)

EXPERIMENTAL

Single Dose Radiotherapy (SDRT) at a prescription dose of 24 Gy to all detectable metastatic lesions

Radiation: Single Dose Radiotherapy (SDRT)

Interventions

Single Dose Radiotherapy (SDRT)RADIATION
Single Dose Radiotherapy (SDRT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologic confirmation of malignancy;
  • FDG PET/CT (or other tracer) PET/CT evidence of limited (1-5) metastases;
  • All detectable lesions must be considered amenable to SDRT or hypofractionated ablation;
  • Age ≥ 18 years;
  • Life expectancy \> 6 months;
  • EGOG Performance Status 0-2;
  • Signed informed consent form for treatment;

You may not qualify if:

  • Overt poly-metastatic disease (≥5 lesions) as shown by PET/CT scanning;
  • Performance status \>2;
  • Severe, active co-morbidity;
  • Significant psychiatric illness;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Champalimaud Centre for the Unknown

Lisbon, Lisbon District, 1800, Portugal

Location

Related Publications (1)

  • Greco C, Kolesnick R, Fuks Z. Conformal Avoidance of Normal Organs at Risk by Perfusion-Modulated Dose Sculpting in Tumor Single-Dose Radiation Therapy. Int J Radiat Oncol Biol Phys. 2021 Jan 1;109(1):288-297. doi: 10.1016/j.ijrobp.2020.08.017. Epub 2020 Aug 7.

    PMID: 32777335DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Carlo Greco, MD

    Fundacao Champalimaud

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 16, 2018

First Posted

June 1, 2018

Study Start

December 1, 2011

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

May 5, 2026

Record last verified: 2026-05

Locations

PT(1)