RecruitingPhase 2

Investigating the Effectiveness of Stereotactic Body Radiotherapy (SBRT) in Addition to Standard of Care Treatment for Cancer That Has Spread Beyond the Original Site of Disease

PROMISE-005: A Phase II Randomized Study Assessing the Efficacy of Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Breast or Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding SBRT, a focused type of radiation, to usual cancer care can delay cancer getting worse. It is for adults with breast cancer or certain types of lung cancer that have spread to 1–5 sites.

This study is being done to determine if stereotactic body radiotherapy (SBRT) when delivered to all sites of disease in participants with 1-5 metastases will increase the length of time before participants' disease gets worse.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older and able to give informed consent, meaning you understand and agree to join.
  • Have breast cancer or non-small cell lung cancer that has spread, confirmed by scans and a tissue test. Lung cancer with EGFR, ALK, or ROS1 gene changes must have gotten worse on the first targeted drug treatment.
  • The cancer spread is newly found, or scans show it has not worsened during at least 3 months of treatment that works throughout the body.
  • Have cancer that can be measured and no more than 5 separate disease sites suitable for SBRT. Some nearby spots may count as one site. Other local treatments may be allowed after discussion with the study lead.
  • If cancer had spread when first diagnosed, the original cancer must be treatable directly. Cancer that returns at or near a previously treated site must also be treatable directly.
  • Any brain cancer spots must be treated before joining. Prior radiation for symptoms is allowed if at least one other spot has not had radiation and can receive SBRT.
  • Be able to care for yourself and be out of bed or a chair for more than half the day. Your organs must work well enough for safe radiation treatment.
  • Women must be unable to become pregnant or have a negative blood pregnancy test within 2 weeks before treatment starts.

Who can't join

  • Have a serious health problem that makes radiation unsafe, as judged by the study doctor.
  • Are pregnant or breastfeeding.
  • Have had another active cancer within the past year, even if no cancer can now be found.
  • Have signs on an exam or scan that cancer is pressing on the spinal cord.
  • Have cancer-related fluid buildup around the lungs or in the belly.
  • Joining would cause an unacceptable delay in planned care.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Metastatic disease detected on imaging and histologically confirmed * Metastatic breast cancer (all subtypes) * Non-small cell lung cancer (NSCLC) without known targetable molecular alterations in EGFR, ALK, or ROS1 * NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations who had a history of disease progression on first-line tyrosine kinase inhibitor * Patient can either have newly diagnosed metastatic disease, or have non-progressive disease on systemic therapy (for at least 3 months on systemic imaging) * Patients must have measurable disease at baseline (RECIST or PERCIST 2.0) and with 5 or fewer discrete disease sites that are technically amendable to SBRT (with the exception that if the primary disease is not amendable to SBRT it is allowed to be treated with conventionally fractionated or hypfractionated radiotherapy). * Two lesions in such close proximity to one another that treatment with one isocenter is more accurate and safer in the liver, lungs, or other similar anatomic locations should be viewed as one site of metastatic disease treatment * Disease in 2 contiguous vertebral bodies (with up to 6 cm of paraspinal extension) can represent one site of disease in the spine; non-contiguous lesions in vertebral bodies separated by one vertebral body free of disease should be viewed as 2 sites of treatment * If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI. * For de novo stage IV patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy. If the primary tumor or other locoregional disease has not been definitively treated and is not amendable to SBRT, it must be treated with conventionally fractionated or hypofractionated radiotherapy using a regimen that delivers a minimum BED of 48 Gy10. If the clinical scenario deem that other forms of local therapy may be more suitable for the primary and locoregional disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI. * If primary disease was previously treated with local therapy in the form of surgery or radiation, any new local/regional disease recurrence should be technically treatable with SBRT or hypofractionated radiation. If the clinical scenario deem that other forms of local therapy may be more suitable for the local/regional recurrent disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy with discussion with the PI. * Patients may receive palliative radiotherapy for symptomatic metastases or primary disease prior to enrollment provided that there is at least one other non-irradiated lesion amenable to SBRT at the time of enrollment. * Patients with brain metastases are eligible if these lesions have been treated prior to enrollment. * ECOG Performance status 0 - 2. * Age \>/= 18 years. * Able to provide informed consent. * Female subjects must either be of non-reproductive potential (i.e. post-menopausal by history: \>/= 60 years old or no menses for 1\> year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test within 2 weeks prior to starting treatment. * Adequate baseline organ function to allow SBRT to all relevant targets, as determined by the treating radiation oncologist based on lesion location, lesion size, and proximity to relevant organs at risk. Exclusion Criteria: * Serious medical co-morbidities precluding radiotherapy, determined at the discretion of the treating investigator. * Pregnant or lactating women. * Other active malignancy within the last year, even if without evidence of disease. * Clinical or radiological evidence of spinal cord compression * Malignant pleural effusion or ascites. * Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.

Study sites (12)

CA

CT

FL

NJ

NY

PA