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Spots Global Cancer Trial Database for Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases

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Trial Identification

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

Official Title: Extracranial Stereotactic Body Radiation Therapy (SBRT) Added to Standard Treatment Versus Standard Treatment Alone in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases

Study ID: NCT03143322

Interventions

SBRT

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

ICO - Site Paul Papin, Angers, , France

Centre Marie Curie, Arras, , France

Hôpital Privé Les Bonnettes, Arras, , France

Institut Sainte Catherine, Avignon, , France

Centre Pierre Curie, Beuvry, , France

Clinique Ambroise Pare, Beuvry, , France

Clinique Tivoli Ducos, Bordeaux, , France

Institut Bergonié, Bordeaux, , France

Pôle Leonard de Vinci, Chambray-lès-Tours, , France

Hôpital Métropole Savoie, Chambéry, , France

Centre Amethyst CROM, Creil, , France

Hôpital Henri Mondor, Créteil, , France

Centre Léonard de Vinci, Dechy, , France

Centre Georges Francois Leclerc, Dijon, , France

Institut de Cancérologie de Bourgogne, Dijon, , France

Chu Grenoble, Grenoble, , France

Centre de Radiothérapie Hartmann, Levallois Perret, , France

Centre Oscar Lambret, Lille, , France

Hôpital Privé Le Bois, Lille, , France

Centre Léon Bérard, Lyon, , France

Institut Paoli Calmettes, Marseille, , France

Centre de Cancérologie du Grand Montpellier, Montpellier, , France

Institut de Cancérologie de Lorraine, Nancy, , France

Institut de Cancérologie de l'Ouest, Nantes, , France

Centre Catalan D'Oncologie, Perpignan, , France

Institut Jean Godinot, Reims, , France

Centre Eugène Marquis, Rennes, , France

Centre Henri Becquerel, Rouen, , France

Centre d'oncologie et radiothérapie Saint-Jean, Saint-doulchard, , France

CHU Saint-Etienne, Saint-Étienne, , France

GCS RISSA - Institut de cancérologie Paris Nord, Sarcelles, , France

Centre Marie Curie, Valence, , France

Clinique des dentellières, Valenciennes, , France

Centre d'Oncologie Saint Yves, Vannes, , France

Contact Details

Name: Sebastien Thureau, MD

Affiliation: Centre Henri Becquerel

Role: PRINCIPAL_INVESTIGATOR

Name: Jean-Christophe Faivre, MD

Affiliation: Institut de Cancérologie de Lorraine - Alexis Vautrin

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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