Clinical trial · Interventional
Phase II Trial Assessing the Efficacy of Immuno-Radiation Abscopal Effect in Patients With Metastatic Cancers
Phase II Trial Assessing the Efficacy of Immuno-Radiation Abscopal Effect in Patients With Metastatic Cancers (IRAM)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No patient enrolled during the authorized period
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Head and Neck Cancer | Malignant Head and Neck Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Systemic treatment | Other | — | UNRESOLVED |
| Systemic treatment + Stereotactic Body Radio-Therapy (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Systemic treatment + Stereotactic Body Radio-Therapy (SBRT)
- description
- 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).
- interventionNames
- Radiation: Systemic treatment + Stereotactic Body Radio-Therapy (SBRT)
- type
- ACTIVE_COMPARATOR
- label
- Systemic treatment
- description
- 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.
- interventionNames
- Other: Systemic treatment
Primary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available