A Phase 2 interventional study of Systemic treatment + Stereotactic Body Radio-Therapy (SBRT) and Systemic treatment in Metastatic Breast Cancer, Metastatic Colorectal Cancer and Metastatic Head and Neck Cancer, sponsored by Institut de Cancérologie de la Loire. Withdrawn at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-30.
Sponsored by Institut de Cancérologie de la Loire · Phase 2, Interventional, and Treatment
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Among 1,208 studies in Breast Neoplasms with a site in France — 207 open to participants now, 342 under way, 83 of them phase 3. Breast Neoplasms · France.
Among the 1,208 studies in Breast Neoplasms with a site in France, this one is the 985th largest by enrollment of the 997 interventional ones that give a count, is one of 64 that started in 2019, is one of 247 in phase 2, and was the 659th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →207 of the 1,208 studies in Breast Neoplasms with a site in France are open now. Recruiting first, the newest first:
Institut Claudius Regaud · Sites in France
Ages 66+ · Men only
Daiichi Sankyo · Sites in France, United States, Belgium and 5 more countries
Ages 18+
Centre Antoine Lacassagne · Sites in France
Ages 18–75
Institut Bergonié · Sites in France
Ages 15–49
Institut du Cancer de Montpellier - Val d'Aurelle · Sites in France
Ages 18+ · Women only
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,208 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 146 · Phase 2 324 · Phase 3 254 · Phase 4 17
First in 1990; this study’s year is marked. 64 started in 2019.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 150 across the 997 interventional studies, 200 across the 202 observational. Of the 787 that completed or were terminated, 254 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
449 of 1,208 have an industry lead sponsor. The 10 most frequent:
Institut de Cancérologie de la Loire is the lead sponsor of 28 studies on the registry; none are open to participants now.
Institut de Cancérologie de la Loire has 4 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
79 of the studies in Breast Neoplasms with a site in France that are under way reach primary completion within a year, 18 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03820830Phase 3ETOP IBCSG Partners FoundationPalbociclib for HR Positive / HER2-negative Isolated Locoregional Recurrence of Breast Cancer | 2026-12 |
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04208178Phase 3Novartis PharmaceuticalsStudy of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation | 2027-02-26 |
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| NCT05696626Phase 3LeonaBioEvaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation | 2027-04 |
Add all 79 to your calendar (.ics) → With an account.
Among the 1,208 studies in Breast Neoplasms with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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 effect called "abscopal". This effect is based on the immune-stimulating effect of high doses ionizing radiations, but also on synergistic association with systemic treatment with immunologic mechanisms. This effect could enhance the tumor local control, but also its distant control.
Numerous preclinical evidences as well as some clinical case reports described the abscopal effect.
Ongoing clinical studies are investigating with radiotherapy abscopal effect alone, or associated with immunotherapies (anti-CTLA-4, PD-1 or PDL-1). The present study proposes a new association, based on an original biological rational. 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 an additive/synergistic way the benefic impact of immune system activation on tumor control.
In the present study, Stereotactic Body Radio-Therapy (SBRT) will be combined to the standard systemic treatment for first line treatment of metastatic breast, colorectal and VADS (upper aerodigestive tract) cancers. Indeed, these treatments have in common the use of target therapies capable of ADCC.
The IRAM study objective is to highlight a possible abscopal effect of this combination for metastatic cancer patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Radiation: Systemic treatment + 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.
Other: Systemic treatment
According to the usual practice, patients will receive their systemic treatment, composed of : * Taxane + trastuzumab +pertuzumab for metastatic breast cancers; * FOLFOX or FOLFIRI + cetuximab for metastatic colorectal cancers; * 5FU-Platine + cetuximab for metastatic head and neck cancers; for six cycles and a maintenance of the targeted therapy until progression or unacceptable toxicity. If progression occurs before the 6th cycles, patients could receive a different line of treatment, according to the usual practice. In addition to the systemic treatment, patients randomized into this experimental group will receive a SBRT of 45Gy in 3 fractions for hepatic and pulmonary metastasis, 27Gy in 3 fractions for bone metastasis and 33 Gy in 3 fractions for intra-cranial metastasis.
According to the usual practice, patients will receive their systemic treatment, composed of : * Taxane + trastuzumab +pertuzumab for metastatic breast cancers; * FOLFOX or FOLFIRI + cetuximab for metastatic colorectal cancers; * 5FU-Platine + cetuximab for metastatic head and neck cancers; for six cycles and a maintenance of the targeted therapy until progression or unacceptable toxicity. If progression occurs before the 6th cycles, patients could receive a different line of treatment, according to the usual practice.
This study also gives Trastuzumab, Pertuzumab. No intervention listed here names it: that was found by reading the record.
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.
Time frame: 18 months
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.
Time frame: 6 months
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.
Time frame: 9 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 5 years
Overall survival (OS)
The OS will be reported at 5 years after the beginning of the systemic treatment.
Time frame: 5 years
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.
Time frame: 6 cycles
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.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jan 2019; primary completion for Feb 2021, 25 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Institut de Cancérologie de la Loire