Trial Summary
What is the purpose of this trial?This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.
Is locally ablative therapy a promising treatment for oligoprogressive cancer?Yes, locally ablative therapy, like Stereotactic Ablative Radiotherapy (SABR), is promising for treating oligoprogressive cancer. It is a precise, noninvasive treatment that can improve survival rates and control cancer spread effectively. It is considered safe and can be combined with other treatments to enhance outcomes.34679
What safety data is available for ablative therapy in cancer treatment?Stereotactic Ablative Radiotherapy (SABR), also known as Locally Ablative Therapy or Stereotactic Body Radiotherapy (SBRT), has been shown to be generally safe and minimally toxic, with rare serious complications. Studies indicate that SABR is effective in controlling tumors with low probability of severe toxicities, though some patients may experience subclinical radiological changes. Strategies to mitigate risks are important, and ongoing trials aim to validate safety and refine patient selection. SABR is considered a preferred treatment for oligometastatic and oligoprogressive cancer due to its high local control rates and potential survival benefits.123710
What data supports the idea that Ablative Therapy for Oligoprogressive Cancer is an effective treatment?The available research shows that Ablative Therapy, specifically Stereotactic Ablative Radiotherapy (SABR), is effective for treating oligoprogressive cancer. It achieves high local control rates of about 80% and can be 'curative' in 20-25% of cases. SABR is also associated with prolonged survival in patients with certain types of cancer, like non-small cell lung cancer (NSCLC). Compared to standard treatments, SABR is noninvasive, has low toxicity, and can improve survival rates, making it a preferred option for targeting multiple cancer sites.35789
Do I have to stop taking my current medications?No, you do not have to stop taking your current medications. The trial requires you to continue your current systemic therapy, with a possible 30-day break for local ablative therapy.
Eligibility Criteria
Adults over 18 with certain cancers (like breast, gynecological, head and neck, sarcomas) who have up to 5 new or worsening metastatic lesions. They must be on systemic therapy they can continue post-treatment and have seen benefits from it for at least 3 months. Not eligible if they have progressing brain tumors or health issues that rule out local therapies.Inclusion Criteria
I am 18 years old or older.
I have 5 or fewer new or growing cancer spots.
My cancer is confirmed to be in the urinary-genital area.
I have cancer in my head or neck.
Exclusion Criteria
I have side effects from past treatments that prevent me from getting certain local therapies.
My brain tumor is getting worse.
Treatment Details
The VALOROUS trial is testing whether adding local ablative treatments (like radiation) to ongoing systemic cancer therapy helps control the disease better in patients whose cancer has started to progress again but only in a limited number of spots.
1Treatment groups
Experimental Treatment
Group I: Ablative local therapyExperimental Treatment1 Intervention
Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
Locally ablative therapy is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as SAbR/SBRT for:
- Oligometastatic pulmonary disease from gastrointestinal malignancies
- Solid tumors
🇺🇸 Approved in United States as SAbR/SBRT for:
- Oligometastatic pulmonary disease from gastrointestinal malignancies
- Solid tumors
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of California, DavisSacramento, CA
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Who is running the clinical trial?
University of California, DavisLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Hypofractionated image-guided breath-hold SABR (stereotactic ablative body radiotherapy) of liver metastases--clinical results. [2021]Stereotactic Ablative Body Radiotherapy (SABR) is a non-invasive therapy option for inoperable liver oligometastases. Outcome and toxicity were retrospectively evaluated in a single-institution patient cohort who had undergone ultrasound-guided breath-hold SABR.
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]The clinical applications of stereotactic body radiotherapy or stereotactic ablative radiotherapy (SABR) for the treatment of primary and metastatic tumours of different organ sites have been expanding rapidly in the recent decade. SABR requires advanced technology in radiotherapy planning and image guidance to deliver a highly conformal ablative dose precisely to targets (or tumours) in the body. Although this treatment modality has shown promising results with regard to tumour control, some serious complications have been observed and reported. In order to achieve a favourable therapeutic ratio, strategies to mitigate the risk of complications must be in place. This overview will summarise the reported serious complications caused by SABR and strategies to mitigate the risk will be discussed.
New concepts and insights into the role of radiation therapy in extracranial metastatic disease. [2013]Stereotactic ablative radiotherapy (SABR) is a form of very precise radiotherapy that delivers high doses to tumors while sparing adjacent organs at risk. Recent data show that SABR is a low-toxic and highly effective local treatment for metastatic localizations in various organs, obtaining local control rates of approximately 80%. Experimental evidence also suggests that SABR may play an important therapeutic role in oligometastatic/oligorecurrent/oligoprogressive patients, a subset of cancer patients who are probably in an intermediate disease state between localized disease and widespread dissemination. There is a strong biological and clinical rationale in combining the high local control rates achievable with SABR with effective systemic therapies, and recent results of pilot studies indicate that SABR may have a potential impact on prognosis in this subgroup of patients, being 'curative' in around 20-25% of cases. This paper reviews and discusses basic concepts and clinical applications of SABR in oligometastatic patients.
Radiation Therapy for Oligometastatic Non-Small Cell Lung Cancer: Theory and Practice. [2015]Management paradigms for metastatic non-small cell lung cancer (mNSCLC) are evolving. Locally ablative therapies are now being increasingly integrated into combined-modality treatment strategies for mNSCLC patients with limited burdens of metastatic foci, termed oligometastases. Concurrently, techniques allowing for precise high-dose radiotherapy delivered over 1 to 5 total treatments, termed stereotactic body radiation therapy (SBRT) or stereotactic ablative radiation therapy (SABR), have emerged as a powerful means of noninvasive tumor ablation with broad patient candidacy. Strong rationale exists for ablative therapy in the setting of oligometastatic NSCLC, including patterns-of-failure analyses and data supporting local ablation of oligoprogressive disease for patients with oncogene-addicted mNSCLC treated with tyrosine kinase inhibitors. In this article, we examine the theoretical basis for ablation of oligometastatic NSCLC and review the growing clinical literature of mNSCLC patients treated with ablative radiation therapy.
Retrospective analysis of stereotactic ablative radiotherapy (SABR) for metastatic lung lesions (MLLs) in comparison with a contemporaneous cohort of primary lung lesions (PLLs). [2020]The net benefit from local ablative therapy for pulmonary oligometastases remains unknown. The outcomes of stereotactic ablative radiotherapy (SABR) for metastatic lung lesions (MLLs) were analyzed retrospectively and compared with those of SABR for primary lung lesions (PLLs).
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]Stereotactic ablative body radiotherapy (SABR) is an emerging noninvasive approach for the treatment of oligometastases. Limited prospective evidence is available in breast cancer.
Radiation in the Treatment of Oligometastatic and Oligoprogressive Disease: Rationale, Recent Data, and Research Questions. [2021]The use of local ablative therapy or metastasis-directed therapy is an emerging management paradigm in oligometastatic and oligoprogressive cancer. Recent randomized evidence has demonstrated that stereotactic ablative radiotherapy (SABR) targeting all metastatic deposits is tolerable and can improve progression-free and overall survival. While SABR is noninvasive, minimally toxic, and generally safe, rare grade 5 events have been reported. Given this and recognizing the often-uncertain prognosis of patients with metastatic disease, equipoise persists regarding the therapeutic window within which to deploy SABR for this indication. Ongoing phase III trials are aimed at validating the demonstrated safety, tolerability, and survival benefits while also refining patient selection, possibly with the aid of novel biomarkers. This narrative review of the role of SABR in oligometastatic and oligoprogressive disease summarizes recent randomized evidence and ongoing clinical trials, discusses our rationale for treatment and key management principles, and posits that SABR should be considered the preferred modality for multisite, metastasis-directed ablative therapy.
Consolidative stereotactic ablative radiotherapy (SABR) to intrapulmonary lesions is associated with prolonged progression-free survival and overall survival in oligometastatic NSCLC patients: A prospective phase 2 study. [2021]Stereotactic Ablative Radiotherapy (SABR) has shown high rates of local control and prolonged survival in early-stage non-small cell lung cancer (NSCLC), though its role in oligometastatic disease is undefined. This study aimed to evaluate SABR as a local consolidative therapy (LCT) in oligometastatic NSCLC patients.
Stereotactic Ablative Radiotherapy for oligo-progressive disease refractory to systemic therapy in Non-Small Cell Lung Cancer: A registry-based phase II randomized trial (SUPPRESS-NSCLC). [2022]Management of Non-Small Cell Lung Cancer (NSCLC) patients with oligoprogression remains controversial. There is limited data to support the strategy of Stereotactic Ablative Radiotherapy (SABR) targeting the oligoprogressive disease in combination with ongoing systemic treatment. We aim to assess the benefit of this approach compared to standard of care in the treatment of oligoprogressive NSCLC.
Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. [2023]Stereotactic ablative radiation therapy (SABR) is the standard of care for inoperable early-stage non-small-cell lung cancer. Although the probability of grade ≥ II toxicities is low, many patients present radiological subclinical toxicities usually associated with long-term patient management challenges. We evaluated radiological changes and correlated them with the received Biological Equivalent Dose (BED).