[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06103669":3,"trial-entities:NCT06103669":89,"trial-summary:NCT06103669":96},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":37,"secondary_outcomes":42,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":62,"locations":65,"central_contacts":83,"overall_officials":85,"references":87,"see_also_links":88},"NCT06103669","UCDCC314","Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)","RECRUITING","2033-12","2026-07","2026-07-08","2023-10-05","University of California, Davis","OTHER",true,"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.","This is a phase 2 pragmatic study at a single site 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 endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. Participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. Participants will be assigned stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy per the discretion of treating radiation oncologist and\u002For interventional radiologist.",[18,19,20,21,22],"Breast Cancer","Oligoprogressive","Head and Neck Cancer","Sarcoma","Other Cancer",[],"INTERVENTIONAL","TREATMENT",[27],"NA",{"count":29,"type":30},250,"ESTIMATED",[32],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Ablative local therapy","Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy",[34],[38],{"measure":39,"description":40,"timeFrame":41},"Number of participants with controlled disease","Number of participants with controlled disease at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy","3 months from the first day of ablative local therapy",[43,47,51],{"measure":44,"description":45,"timeFrame":46},"Number of participants experiencing grade ≥ 3 adverse events attributable to ablative local therapy","Number of participants experiencing grade ≥ 3 adverse events (except for hematologic and electrolyte abnormalities) attributable to ablative local therapy occurring up to 2 years from the first day of ablative local therapy","Up to 2 years from the first day of ablative local therapy",{"measure":48,"description":49,"timeFrame":50},"Median overall survival","Median overall survival stratified by primary tumor type","Up to 1 year from the first day of ablative local therapy",{"measure":52,"description":53,"timeFrame":50},"Time to treatment failure","Time to treatment failure, defined as time to change in systemic therapy or permanent discontinuation of cancer therapy","ALL","18 Years",null,false,{"inclusion":59,"exclusion":60,"raw_text":61},[],[],"Inclusion Criteria:\n\n1. Must have one of the following histologically and\u002For biochemically confirmed genitourinary malignancies:\n\n   1. Cohort A: Breast Malignancy\n   2. Cohort B: Gynecological Malignancy\n   3. Cohort C: Head and Neck Malignancies\n   4. Cohort D: Sarcomas\n   5. Cohort E: Other solid malignancy specified in the protocol\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \\[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\\]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and\u002F interventional radiologist.\n\nExclusion Criteria:\n\n1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":12,"status":7,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":80},"Sacramento","California","95817","United States",[72,77],{"name":73,"role":74,"phone":75,"email":76},"Office of Clinical Research","CONTACT","916-382-6970","OCRReferral@health.ucdavis.edu",{"name":78,"role":79},"Xiao Zhao, MD","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},38.58157,-121.4944,[84],{"name":73,"role":74,"phone":75,"email":76},[86],{"name":78,"affiliation":12,"role":79},[],[],{"nct_id":4,"conditions":90,"biomarkers":95},[91,92,93,21,94],"Breast Carcinoma","Gynecological Malignancy","Malignant Head and Neck Neoplasm","Solid Neoplasm",[],{"nct_id":4,"found":14,"summary":97,"prompt_version":107},{"design":98,"status":99,"heading":100,"summary":101,"follow_up":102,"word_count":103,"commitments":104,"compensation":105,"drugs_mentioned":106},"This is a Phase 2 study at a single location, aiming to enroll 250 participants. It is an interventional study, meaning participants will receive a specific treatment.","completed","VALOROUS Study: Local Therapy for Oligo-Progressive Cancers","This study, called VALOROUS, is looking at whether adding local treatments like stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy can help people with certain cancers that have started to grow in a few spots (oligo-progressive solid tumors). These local treatments are given in addition to your regular cancer medicine. The study wants to see if these added treatments can help keep your disease under control for at least 3 months. You might be able to join if you are 18 or older and have breast, gynecological, head and neck, sarcoma, or other solid cancers. The study is currently unclear about its recruitment status and plans to enroll 250 participants.","Participants will be followed for up to 5 years after receiving ablative local therapy.",112,"Participants will receive ablative local therapy in addition to their systemic therapy. They will be followed for up to 5 years after the local therapy.","Not stated in the trial record.",[],"v2"]