Metastatic Breast Cancer Clinical Trial
Official title:
Phase II Trial Assessing the Efficacy of Immuno-Radiation Abscopal Effect in Patients With Metastatic Cancers (IRAM)
The proposed theory is based on combination of radiation therapy with usual targeted therapies capable of ADCC (Antibody-Dependant Cell Cytotoxicity). This association could enhance in a additive/synergistic way the benefic impact of immune system activation on tumor control. Stereotactic Body Radio-Therapy (SBRT) will be combined with the first line chemotherapy for metastatic breast, colorectal or VADS (upper aerodigestive tract) cancers. The IRAM study objective is to highlight a possible abscopal effect of this combination for metastatic cancer patients.
Nowadays, metastatic cancer treatment is evolving with systemic treatments (target therapies
and immunotherapies). Combinations and new therapeutic schemes have recently boosted the
interest for an effect called "abscopal". This effect is based on the immune-stimulating
effect of high doses ionizing radiations, but also on synergistic association with systemic
treatment with immunologic mechanisms. This effect could enhance the tumor local control, but
also its distant control.
Numerous preclinical evidences as well as some clinical case reports described the abscopal
effect.
Ongoing clinical studies are investigating with radiotherapy abscopal effect alone, or
associated with immunotherapies (anti-CTLA-4, PD-1 or PDL-1). The present study proposes a
new association, based on an original biological rational. The proposed theory is based on
combination of radiation therapy with usual targeted therapies capable of ADCC
(Antibody-Dependant Cell Cytotoxicity). This association could enhance in an
additive/synergistic way the benefic impact of immune system activation on tumor control.
In the present study, Stereotactic Body Radio-Therapy (SBRT) will be combined to the standard
systemic treatment for first line treatment of metastatic breast, colorectal and VADS (upper
aerodigestive tract) cancers. Indeed, these treatments have in common the use of target
therapies capable of ADCC.
The IRAM study objective is to highlight a possible abscopal effect of this combination for
metastatic cancer patients.
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