Status:
WITHDRAWN
Phase II Trial Assessing the Efficacy of Immuno-Radiation Abscopal Effect in Patients With Metastatic Cancers
Lead Sponsor:
Institut de Cancérologie de la Loire
Collaborating Sponsors:
Saint-Louis Hospital, Paris, France
Gustave Roussy, Cancer Campus, Grand Paris
Conditions:
Metastatic Breast Cancer
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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/syne...
Detailed Description
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 ef...
Eligibility Criteria
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 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03323424
Start Date
January 1 2019
End Date
February 1 2026
Last Update
January 30 2020
Active Locations (6)
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1
Clinique Claude Bernard
Albi, France, 81000
2
Centre Léonard de Vinci
Dechy, France, 59507
3
Centre Hospitalier Privé Saint Gregoire
Saint-Grégoire, France, 35760
4
CHU de St-Etienne
Saint-Priest-en-Jarez, France, 42270