Phase II Trial Assessing the Efficacy of Immuno-Radiation Abscopal Effect in Patients With Metastatic Cancers (IRAM)
Metastatic Breast Cancer, Metastatic Colorectal Cancer, Metastatic Head and Neck Cancer
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Metastatic cancer, Abscopal effect, Ionizing radiation, Antibody-Dependant Cell Cytotoxicity (ADCC), Immuno-Radiation effect, Stereotactic Body Radio-Therapy (SBRT), Targeted therapies
Eligibility Criteria
Inclusion Criteria:
- Patients with a metastatic breast adenocarcinoma HER2+, a metastatic squamous carcinoma of VADS, or a colorectal adenocarcinoma with a wild status for RAS (NRAS and KRAS)
- Patient presenting at least two measurable metastases (according to the RECIST v1.1 criteria):
- At least one eligible to SBRT (hepatic, pulmonary, bone or intra-cranial metastasis, with a diameter between 1 and 4cm)
- At least one non irradiated measurable metastasis
- Performance Status corresponding to 0, 1, or 2
- Realisation of a PET (Positron Emission Tomography)-Scanner and a TAP (Thoraco-AbdominoPelvic)-Scanner 30 days maximum before inclusion
- Informed consent patient
- Patients affiliated to a social security scheme.
Exclusion Criteria:
- Patient presenting a known non-indication or contraindication to the first line treatment administered
- Pregnant or nursing women
- Patient with an another cancer during the 5 last years, excepting basocellular carcinoma, and skin epidermoid carcinoma
- Patient presenting a non-controlled pain linked to the cancer
- Patient presenting a non-controlled hypercalcemia or symptomatic hypercalcemia needing an ongoing use of bisphosphonates or denosumab.
- Patient presenting an inflammatory pathology or active autoimmune pathology or history of.
- Patient having received one or more vaccines during the 4 weeks preceding the beginning of the systemic treatment.
- Patient currently using corticosteroids or other immune-suppressors during the two weeks before inclusion, and any other situation where this kind of treatments could be necessary during the study.
- Patient deprive of liberty or under administrative supervision, patients with an impossible take care supervision for psychological or geographical reasons.
- Stereotactic Body Radio-Therapy (SBRT) must not include metastases localized in the 3 centimeters of the structure previously irradiated.
- Patient presenting serious active comorbidities defined by the protocol.
- Known seropositivity to the HIV
Sites / Locations
- Clinique Claude Bernard
- Centre Léonard de Vinci
- Centre Hospitalier Privé Saint Gregoire
- CHU de St-Etienne
- Institut de Cancérologie Lucien Neuwirth
- Centre Marie Curie
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Systemic treatment + Stereotactic Body Radio-Therapy (SBRT)
Systemic treatment
Patients with metastatic breast, colorectal or head or neck cancers and corresponding with the inclusion criteria will receive a systemic treatment, according to the usual practice, but also a Stereotactic Body Radio-Therapy (SBRT).
Patients with metastatic breast, colorectal or head or neck cancers and corresponding with the inclusion criteria will receive a systemic treatment, according to the usual practice.