Ablative Therapy for Oligoprogressive Cancer
(VALOROUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the benefits of combining local treatments with ongoing medication for individuals with certain cancers that have spread moderately. The focus includes breast, gynecological, head and neck, and other solid tumors. Local treatments, such as targeted radiation or ablation (locally ablative therapy), aim to halt or slow new tumor growth. This trial suits those whose treatment has mostly stabilized their cancer but who have developed a few new spots. Participants should have no more than five new or growing spots that can be safely treated with these local therapies. As an unphased trial, this study provides a unique opportunity to explore innovative treatment combinations that might better control cancer.
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 prior data suggests that locally ablative therapy is safe for treating oligo-progressive solid tumors?
Research has shown that treatments like stereotactic ablative radiotherapy (SABR) are generally safe and well-tolerated. Studies have found that SABR effectively treats certain cancers, particularly those with limited spread or slow growth. For instance, some studies indicate that patients can safely undergo multiple rounds of SABR, suggesting it is not only effective but also manageable over time. While some side effects might occur, many patients consider these treatments safe.12345
Why are researchers excited about this trial?
Researchers are excited about locally ablative therapy for oligoprogressive cancer because it offers a targeted approach that directly attacks cancer cells in specific areas, unlike traditional therapies that often affect the whole body. This method uses stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation to precisely focus on tumors, minimizing damage to surrounding healthy tissue. By concentrating treatment on progression spots, it can potentially control the disease more effectively and with fewer side effects than systemic treatments like chemotherapy or broad radiation therapy. This specificity might allow for better quality of life and faster recovery for patients.
What evidence suggests that locally ablative therapy is effective for oligoprogressive cancer?
Research has shown that treatments like Stereotactic Ablative Radiotherapy (SABR), studied in this trial as part of the ablative local therapy arm, can effectively treat oligoprogressive cancer. Studies have found that SABR can extend patient survival and delay the need to alter overall cancer treatment. For certain cancer types, this method proves both effective and manageable. The therapy targets and destroys specific cancer areas, helping control the disease without immediately requiring new medications. Overall, evidence supports this treatment as a valuable option for managing cancer progression.26789
Who Is on the Research Team?
Xiao Zhao, MD
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive systemic therapy with the addition of locally ablative therapies such as stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy
Follow-up
Participants are monitored for disease control and adverse events after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Locally ablative therapy
Locally ablative therapy is already approved in European Union, United States for the following indications:
- Oligometastatic pulmonary disease from gastrointestinal malignancies
- Solid tumors
- Oligometastatic pulmonary disease from gastrointestinal malignancies
- Solid tumors
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor
National Cancer Institute (NCI)
Collaborator