Ablative Therapy for Oligoprogressive Cancer
(VALOROUS Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Davis
Must be taking: Systemic therapy
Disqualifiers: Intracranial lesions, others
No Placebo Group
Approved in 2 Jurisdictions
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.
Will I have to stop taking my current medications?
The trial does not require you to stop your current medications. You can continue your current systemic therapy, with a possible break of up to 30 days for the local ablative therapy.
What data supports the effectiveness of this treatment for oligoprogressive cancer?
Research shows that Stereotactic Ablative Radiotherapy (SABR), a precise form of radiation therapy, is effective in controlling tumors in various organs with about 80% success in local control. It has been found to improve survival rates and may even be curative in 20-25% of cases for patients with limited cancer spread, like those with oligoprogressive disease.12345
Is ablative therapy for oligoprogressive cancer safe for humans?
How is the treatment for oligoprogressive cancer different from other treatments?
Locally ablative therapy, such as Stereotactic Ablative Radiotherapy (SABR), is unique because it delivers precise, high-dose radiation to tumors in a few sessions, minimizing damage to surrounding healthy tissue. This noninvasive approach is particularly effective for patients with limited metastatic cancer, offering a potential survival benefit and improved local control compared to standard treatments.123910
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've had at least one treatment for my cancer that spread, and it worked for 3 months before the cancer grew.
My cancer spread can be targeted with specific local treatments.
I am 18 years old or older.
See 10 more
Exclusion Criteria
I have side effects from past treatments that prevent me from getting certain local therapies.
My brain tumor is getting worse.
I have health conditions that prevent me from undergoing treatments targeting specific areas.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive systemic therapy with the addition of locally ablative therapies such as stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
3 months
Visits as per standard practices
Follow-up
Participants are monitored for disease control and adverse events after treatment
Up to 5 years
Regular follow-up visits
Treatment Details
Interventions
- Locally ablative therapy (Procedure)
Trial OverviewThe 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.
Participant Groups
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
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.
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.
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.
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).
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.
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).
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.
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.
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.