A Study to Assess the Ability of Stereotactic Radiotherapy to Restore the Efficacy of Immunotherapy in Patients With Metastatic Cancer.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElsan

About this trial

This study aims at enrolling patients with solid tumors at metastatic stage, considered long responders to immunotherapy (\> 6 months) and displaying disease progression.

In this study, the investigator wants to evaluate specific modalities of stereotactic radiotherapy, with 3 sessions, each of 8 Gy, lasting 20 minutes and spaced 72 hours apart (Day 1, Day 4, Day 7). The radiotherapy device itself is not the subject of this study and will be used in accordance with its CE mark and indications.

The objective of the study is to assess the ability of stereotactic radiotherapy to restore the lost efficacy of immunotherapy. In particular, the abscopal effect will be assessed, i.e. the action of irradiating a particular target lesion and observing an effect on other distant metastases.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female, 18 years of age or older,

Patient with a metastatic solid tumor,

Patient with at least one target lesion (for radiotherapy) together with other secondary lesions that must be measurable,

Measurable disease according to RECIST 1.1 and iRECIST criteria,

Disqualifiers

Patient having received previous radiotherapy since the start of immunotherapy,

Patient for whom first disease progression (pre-inclusion stage) is not confirmed secondarily (inclusion stage),

Patient with an active implantable medical device (e.g. pacemaker) or an active medical device worn on the body that could interact adversely with stereotactic radiotherapy treatment,

Patient with hematological cancer,

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Radiotherapy

    Radiation

    Patients will perform stereotactic radiotherapy with 3 sessions (8 Gy) during 20 minutes each and with 72 hours in-between. Patients enrolled in the study would not have received this stereotactic radiotherapy outside the study, that is why this procedure is additional (compared to Standard of care) and considered as burdensome (as this is radiation). Before performing the stereotactic radiotherapy, patients will do a radiotherapy CT scanner (no injected) in order to prepare precisely the radiotherapy (treatment plan).

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Stereotactic radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate according to iRECIST criteria at 3 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.

Assessment of Objective Response Rate (Complete Response and Partial Response with iRECIST criteria) according to a centralised independent reading.

Time frame
At 3 months after stereotactic radiotherapy

Secondary outcomes

1

Objective Response Rate according to RECIST 1.1 criteria at 3 months after stereotactic RT in patients with progression after initial response to immunotherapy.

Assessment of Objective Response Rate (Complete Response and Partial Response with RECIST 1.1 criteria) according to a centralised independent reading.

Time frame
At 3 months after stereotactic radiotherapy
2

Objective Response Rate according to iRECIST criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.

Time frame
Up to 12 months after stereotactic radiotherapy
3

Objective Response Rate according to RECIST 1.1 criteria up to 12 months after stereotactic radiotherapy in patients with confirmed progression after initial response to immunotherapy.

Time frame
Up to 12 months after stereotactic radiotherapy
4

Duration until new systemic treatment start.

Duration (in days) before introduction of a new systemic treatment.

Time frame
Up to 12 months after stereotactic radiotherapy

Other outcomes

Sponsors and contacts

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