Metastatic Breast Cancer Clinical Trial
— IRAMOfficial title:
Phase II Trial Assessing the Efficacy of Immuno-Radiation Abscopal Effect in Patients With Metastatic Cancers (IRAM)
Verified date | January 2020 |
Source | Institut de Cancérologie de la Loire |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 1, 2026 |
Est. primary completion date | February 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Clinique Claude Bernard | Albi | |
France | Centre Léonard de Vinci | Dechy | |
France | Centre Hospitalier Privé Saint Gregoire | Saint-Grégoire | |
France | CHU de St-Etienne | Saint-Priest-en-Jarez | |
France | Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | |
France | Centre Marie Curie | Valence |
Lead Sponsor | Collaborator |
---|---|
Institut de Cancérologie de la Loire | Gustave Roussy, Cancer Campus, Grand Paris, Saint-Louis Hospital, Paris, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival rate without progression for patients with metastatic breast cancer | The rate of survival without progression according to the RECIST (v1.1) criteria for patients with metastatic breast cancer will be calculated at 18 months after the beginning of the systemic treatment. | 18 months | |
Primary | Survival rate without progression for metastatic head and neck cancer | The rate of survival without progression according to the RECIST (v1.1) criteria for patients with head and neck cancer will be calculated at 6 months after the beginning of the systemic treatment. | 6 months | |
Primary | Survival rate without progression for patients with metastatic colorectal cancer | The rate of survival without progression according to the RECIST (v1.1) criteria for patients with colorectal cancer will be calculated at 9 months after the beginning of the systemic treatment. | 9 months | |
Secondary | Response rate on predetermined metastatic abscopal sites | The response rate on predetermined metastatic abscopal sites will be evaluated at 3 months after the beginning of the systemic treatment according to the RECIST v1.1 criteria. | 3 months | |
Secondary | Response rate on the irradiated site | The response rate on the irradiated site will be evaluated at 3 months after the beginning of the systemic treatment according to the RECIST v1.1 criteria. | 3 months | |
Secondary | Progression-free survival (PFS) | The median PFS according to the RECIST v1.1 criteria will be reported at 5 years after the beginning of the systemic treatment. | 5 years | |
Secondary | Overall survival (OS) | The OS will be reported at 5 years after the beginning of the systemic treatment. | 5 years | |
Secondary | Toxicity of the treatments combination | During the first line of systemic treatment (six cycles of treatment maximum), the number and the grade (CTCAE v4.4) of toxicities related to the systemic treatment /Radiation therapy combination will be reported. | 6 cycles | |
Secondary | Toxicity of the treatments combination | Sub-group analysis will be performed following the 3 binary stratification criteria: total number of metastasis, localization of the irradiated metastasis and irradiated volume. | 5 years |
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