NCT03486431: Destroy

A Dose-escalation Trial of Stereotactic Ablative Body Radiotherapy for Non-spine Bone & Lymph Node Oligometastates

Completed NA Last updated 8 February 2024

What this trial tests

NA trial testing Stereotactic Ablative Radiotherapy (SABR) in Metastatic Cancer in 90 participants. Completed in 31 December 2019.

Timeline

5 July 2017

Primary endpoint
30 June 2019

31 December 2019

Quick facts

Lead sponsor	Cancer Research Antwerp
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	5 July 2017
Primary completion	30 June 2019
Estimated completion	31 December 2019
Sites	1 location across Belgium

Drugs / interventions tested

• Stereotactic Ablative Radiotherapy (SABR)

Conditions studied

• Metastatic Cancer — all drugs for Metastatic Cancer →

Sponsor

Cancer Research Antwerp — full company profile →

Who can join

18 and older, any sex, with Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Stereotactic ablative body radiotherapy (SABR) can be considered for patients with so-called "oligometastatic" disease. However, since this is a relatively new technique, information on the optimal scheduling is lacking. Even prospective randomized trials on SABR for oligometastases typically allow different fractionation schedules to be used. This is especially true for non-spine bone and lymph node metastases, where the literature is scarce to non-existent.

There is also emerging evidence that SABR can stimulate the immune response, by a variety of mechanisms such as increasing TLR4 expression on dendritic cells, increasing priming of T cells in draining lymph nodes, and increasing tumor cell antigen presentation by dendritic cells. Again, it is not clear which fractionation schedule elicits the most robust immune response.

Therefore, it is opportune to compare the most commonly used stereotactic regimens regarding toxicity, efficacy, and immune priming.

This trial is a non-randomized prospective phase I trial determining a regimen of choice for patients with non-spine bone and lymph node oligometastases (≤ 3 lesions). The metastatic lesion(s) must be visible on CT and \< 5 cm in largest diameter. A total of ninety patients will be consecutively included in three different fractionation regimens. They will be offered stereotactic ablative radiotherapy to all metastatic lesions in 5, 3 or 1 fractions. Dose-limiting toxicity (DLT), defined as any acute grade 3 or 4 toxicity, will be recorded as the primary endpoint. Overall acute and late toxicity, quality of life, local control, and progression-free survival are secondary endpoints.

Liquid biopsies will be collected throughout the course of this trial, i.e. at simulation, after each fraction and at 6 months after the end of the radiotherapy. Translational research will focus on assessment of circulating cytokines and flow cytometry analysis of immune cells.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oligometastatic Breast Cancer: Is This a Curable Entity? A Contemporary Review of the Literature.
   Makhlin I, Fox K. · · 2020 · cited 26× · PMID 32025905 · DOI 10.1007/s11912-020-0867-2
2. Stereotactic Ablative Radiation Therapy to All Lesions in Patients With Oligometastatic Cancers: A Phase 1 Dose-Escalation Trial.
   Mercier C, Claessens M, Buys MSc A, Gryshkevych S, et al · · 2021 · cited 8× · PMID 33307151 · DOI 10.1016/j.ijrobp.2020.11.066
3. A phase I dose-escalation trial of stereotactic ablative body radiotherapy for non-spine bone and lymph node metastases (DESTROY-trial).
   Mercier C, Dirix P, Meijnders P, Vermeulen P, et al · · 2018 · cited 5× · PMID 30126440 · DOI 10.1186/s13014-018-1096-9