Clinical Trial: Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 3 Bone-only Metastases

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Extracranial Stereotactic Body Radiation Therapy (SBRT) Added to Standard Treatment Versus Standard Treatment Alone in Solid Tumors Patients With Between 1 and 3 Bone-only Metastases

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 in

Detailed Summary:
Sponsor: UNICANCER

Current Primary Outcome: Progression Free Survival [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• PFS at 2 and 3 years [ Time Frame: 2 years and 3 years after treatment ]
  Progression-Free Survival (PFS) at 2 and 3 years will be evaluated according to RECIST 1.1 and PERCIST
• Bone progression free survival at 1, 2 and 3 years [ Time Frame: 1, 2 and 3 years after treatment ]
  Distant bone progression at 2 and 3 years will be evaluated according to RECIST Criteria 1.1 and at 1 year according to RECIST Criteria 1.1 and PERCIST
• Local control at 1, 2 and 3 years [ Time Frame: 1, 2 and 3 years after treatment ]
  Local control will be evaluated at 1, 2 and 3 years according to RECIST Criteria 1.1 and PERCIST
• Cancer-specific survival [ Time Frame: 1, 2 and 3 years after treatment ]
• Overall survival [ Time Frame: 1, 2 and 3 years after treatment ]
• SBRT toxicities [ Time Frame: 1, 2 and 3 years after treatment ]
  according CTCAE 4.0 scale
• Patient's Quality of life [ Time Frame: at baseline, 6 weeks after randomization, and 3 months, 6 months and 1, 2 and 3 years after treatment ]
  self-administered questionnaire
• Pain score [ Time Frame: at baseline, once a week during 2 weeks and 6 weeks after randomization, and at 3 months, 6 months and 1, 2 and 3 years after treatment ]
  according to Numeric Scale related to pain medication
• Cost utility [ Time Frame: 6 weeks after randomization ]
  QALYs (Quality-Adjusted Life Years) and ICERs (Incremental Cost-Effectiveness Ratios) calculation based on EQ-5D-3L questionnaire.

Original Secondary Outcome: Same as current

Information By: UNICANCER

Dates:
Date Received: April 28, 2017
Date Started: June 1, 2017
Date Completion: July 1, 2022
Last Updated: May 3, 2017
Last Verified: May 2017