NCT03323424

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/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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

October 24, 2017

Last Update Submit

January 28, 2020

Conditions

Metastatic Breast CancerMetastatic Colorectal CancerMetastatic Head and Neck Cancer

Keywords

Metastatic cancerAbscopal effectIonizing radiationAntibody-Dependant Cell Cytotoxicity (ADCC)Immuno-Radiation effectStereotactic Body Radio-Therapy (SBRT)Targeted therapies

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (6)

  • Response rate on predetermined metastatic abscopal sites

    3 months

  • Response rate on the irradiated site

    3 months

  • Progression-free survival (PFS)

    5 years

  • Overall survival (OS)

    5 years

  • Toxicity of the treatments combination

    6 cycles

  • +1 more secondary outcomes

Study Arms (2)

Systemic treatment + Stereotactic Body Radio-Therapy (SBRT)

EXPERIMENTAL

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)

Systemic treatment

ACTIVE COMPARATOR

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

Interventions

Systemic treatment + Stereotactic Body Radio-Therapy (SBRT)RADIATION

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.

Systemic treatment + Stereotactic Body Radio-Therapy (SBRT)
Systemic treatmentOTHER

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.

Systemic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Informed consent patient
  • Patients affiliated to a social security scheme.

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinique Claude Bernard

Albi, 81000, France

Location

Centre Léonard de Vinci

Dechy, 59507, France

Location

Centre Hospitalier Privé Saint Gregoire

Saint-Grégoire, 35760, France

Location

CHU de St-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Centre Marie Curie

Valence, 26000, France

Location

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsHead and Neck NeoplasmsNeoplasm Metastasis

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeutics

Study Officials

  • Nicolas Magné, PhD

    Institut de Cancérologie Lucien Neuwirth

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

October 27, 2017

Study Start

January 1, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2026

Last Updated

January 30, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(6)