Phase II Trial Assessing the Efficacy of Immuno-Radiation Abscopal Effect in Patients With Metastatic Cancers
Reason given: No patient enrolled during the authorized period
Key facts
- Where
- Albi, Dechy, Saint Priest En Jarez, Saint-Grégoire, Saint-Priest-en-Jarez, and Valence, FranceSee the 6 sites
- Phase
- Phase 2
Where in France
- Clinique Claude BernardAlbi, FranceNo longer taking part
- Centre Léonard de VinciDechy, FranceNo longer taking part
- CHU de St EtienneSaint Priest En Jarez, FranceNo longer taking part
- Centre Hospitalier Prive Saint GregoireSaint-Grégoire, FranceNo longer taking part
- Institut de Cancérologie Lucien NeuwirthSaint-Priest-en-Jarez, FranceNo longer taking part
- Centre Marie CurieValence, FranceNo longer taking part
Trial details
- Who runs it
- Institut de Cancérologie de la Loire
- Trial code
- NCT03323424
- Record updated
- 30 January 2020
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; Stereotactic Body Radio-Therapy (SBRT) must not include metastases localized in the 3 centimeters of the structure previously irradiated; 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 an inflammatory pathology or active autoimmune pathology or history of; Known seropositivity to the HIV; Patient presenting a known non-indication or contraindication to the first line treatment administered; Pregnant or nursing women; Patient presenting a non-controlled hypercalcemia or symptomatic hypercalcemia needing an ongoing use of bisphosphonates or denosumab; Patient deprive of liberty or under administrative supervision, patients with an impossible take care supervision for psychological or geographical reasons; Patient presenting serious active comorbidities defined by the protocol.