Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases

Last updated: November 25, 2024
Sponsor: UNICANCER
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Prostate Cancer

Metastatic Cancer

Bone Metastases

Treatment

SBRT

Clinical Study ID

NCT03143322
UC-0107/1603
  • Ages 18-75
  • All Genders

Study Summary

Bone metastases occur frequently during the evolution of solid tumors, either isolated or associated with visceral metastases. The incidence varies between 20 and 85% depending on the primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone metastases. Cancer with bone metastases compared to other metastatic sites is considered as associated with a better prognosis, particularly for breast and prostate cancer. Bone metastases may be present at diagnosis (synchronous metastasis) or appear at a later time (metachronous metastasis).

The concept of "oligometastases" was proposed in patients with about 3 up to 5 metastases (without restriction on the primary site) and associated with an intermediate prognosis. It was hypothesized that local treatment with curative intent, aiming at the few metastatic sites, would yield long-term survival probabilities, along with systemic therapies.

Long-term survivors have been reported after curative-intent treatment of metastasis in sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone metastasis because of their high incidence, their impact on the patient's quality of life and autonomy, and their accessibility to potentially curative radiotherapy.

The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate cancer), biologically-targeted drugs and chemotherapy (all cancers).

Stereotactic radiotherapy is a highly accurate technique was initially developed for performing the radiosurgery of brain tumors in patients for whom it was deemed be too difficult to proceed to classical excision surgery. In this process, a high total dose of radiation is delivered in a single fraction to a well-defined intra-cranial target. The concept of radiotherapy in stereotactic conditions was extended to one or several fractions delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic Body RadioTherapy [SBRT]). At present, high control rates have been achieved for lung metastases. Similarly, very high local control rates have been reported in bone metastases after stereotactic radiotherapy.

In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1 and 5 metastases) in solid tumor patients is able to improve the survival without progression.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients older than 18 years and younger than 75 years

  2. Good general condition: WHO performance status ≤ 2

  3. Patients with histological proof of breast, non-small cell lung, or prostate cancerNote: Histological proof can be done on the primitive tumour and/or adenopathyand/or metastatic site.

  4. Absence of co-morbidity contra-indicating radio-chemotherapy or surgery

  5. Primary tumor accessible to curative-intent treatment (surgery, chemoradiation...)for patients with synchronous metastases

  6. Patients with between 1 and 5 synchronous or metachronous bone metastases as definedby NaF-PET or conventional SPECT-CT scan and spinal MRI (if necessary) within 6weeks before randomization)

  7. Bones metastases treatable by SBRT

  8. Primary cancer considered to be controlled or accessible to curative-intenttreatment (surgery, chemoradiation...) in case of locoregional recurrence formetachronous bone oligo-metastatic disease

  9. Women of childbearing potential and male patients must agree to use adequatecontraception for the duration of study participation and up to 3 months followingcompletion of therapy

  10. Patients who have received the information sheet, dated and signed the informedconsent form

  11. Affiliated to the social security system

Exclusion

Exclusion Criteria:

  1. Visceral metastases as defined by FDG-PET (F-Choline-PET or PSMA PET-CT for prostatecancer) and cerebral CT or MRI performed.

  2. Previous systemic therapy for metastasis for patients with metachronous metastasis.Prostate and breast cancer patients remain eligible if hormonal treatment wasinitiated 6 months before enrollment

  3. All bone metastasis requiring surgical treatment (spinal cord compression,fracture...)

  4. More than 5 bone metastases as defined by NaF-PET or conventional SPECT-CT scan andspinal MRI (if spinal bone metastases on NaF-PET)

  5. Previous cancer within the 5 years before inclusion (except basal cell carcinoma ofthe skin, in situ carcinoma of the uterine cervix)

  6. Previous radiotherapy on bone metastasis (e.g: antalgic radiotherapy)

  7. Patient enrolled in another therapeutic trial

  8. Pregnant women or breast feeding mothers,

  9. Hypersensitivity to the active substance (FDG and NaF or F-Choline or PSMA forprostate cancer) or to any of the excipients

  10. Contraindication to MRI (in case of spinal metastases)

  11. Patients deprived of liberty or placed under the authority of a tutor. Patients withany psychological, familial, sociological or geographical condition potentiallyhampering compliance with the study protocol and follow-up schedule; thoseconditions should be discussed with the patient before registration in the trial.Patients unable to understand the purpose of the study (language, etc.).

Study Design

Total Participants: 168
Treatment Group(s): 1
Primary Treatment: SBRT
Phase:
Study Start date:
July 24, 2018
Estimated Completion Date:
July 22, 2027

Connect with a study center

  • ICO - Site Paul Papin

    Angers,
    France

    Site Not Available

  • Centre Marie Curie

    Arras,
    France

    Site Not Available

  • Hôpital Privé Les Bonnettes

    Arras,
    France

    Site Not Available

  • Institut Sainte Catherine

    Avignon,
    France

    Site Not Available

  • Centre Pierre Curie

    Beuvry,
    France

    Site Not Available

  • Clinique Ambroise Pare

    Beuvry,
    France

    Site Not Available

  • Clinique Tivoli Ducos

    Bordeaux,
    France

    Site Not Available

  • Institut Bergonié

    Bordeaux,
    France

    Site Not Available

  • Pôle Leonard de Vinci

    Chambray-lès-Tours,
    France

    Site Not Available

  • Hôpital Métropole Savoie

    Chambéry,
    France

    Site Not Available

  • Centre Amethyst CROM

    Creil,
    France

    Site Not Available

  • Hôpital Henri Mondor

    Créteil,
    France

    Site Not Available

  • Centre Léonard de Vinci

    Dechy,
    France

    Site Not Available

  • Centre Georges Francois Leclerc

    Dijon,
    France

    Site Not Available

  • Institut de Cancérologie de Bourgogne

    Dijon,
    France

    Site Not Available

  • Chu Grenoble

    Grenoble,
    France

    Site Not Available

  • Centre de Radiothérapie Hartmann

    Levallois Perret,
    France

    Site Not Available

  • Centre Oscar Lambret

    Lille,
    France

    Site Not Available

  • Hôpital Privé Le Bois

    Lille,
    France

    Site Not Available

  • Centre Léon Bérard

    Lyon,
    France

    Site Not Available

  • Institut Paoli Calmettes

    Marseille,
    France

    Site Not Available

  • Centre de Cancérologie du Grand Montpellier

    Montpellier,
    France

    Site Not Available

  • Institut de Cancérologie de Lorraine

    Nancy,
    France

    Site Not Available

  • Institut de Cancérologie de l'Ouest

    Nantes,
    France

    Site Not Available

  • Centre Catalan D'Oncologie

    Perpignan,
    France

    Site Not Available

  • Institut Jean Godinot

    Reims,
    France

    Site Not Available

  • Centre Eugène Marquis

    Rennes,
    France

    Site Not Available

  • Centre Henri Becquerel

    Rouen,
    France

    Site Not Available

  • Centre d'oncologie et radiothérapie Saint-Jean

    Saint-doulchard,
    France

    Site Not Available

  • CHU Saint-Etienne

    Saint-Étienne,
    France

    Site Not Available

  • GCS RISSA - Institut de cancérologie Paris Nord

    Sarcelles,
    France

    Site Not Available

  • Centre Marie Curie

    Valence,
    France

    Site Not Available

  • Clinique des dentellières

    Valenciennes,
    France

    Site Not Available

  • Centre d'Oncologie Saint Yves

    Vannes,
    France

    Site Not Available

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