Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Head and Neck Neoplasms

Sarcoma

Soft Tissue Sarcoma

Stereotactic ablative radiotherapy (SABR) or interventional radiology (IR) ablation therapy

Ablative local therapy

Selina Laqui

Xiao Zhao, MD

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/or interventional radiologist.

Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)

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

Number of participants experiencing grade ≥ 3 adverse events (except for hematologic and electrolyte abnormalities) attributable to ablative local therapy

Median overall survival stratified by primary tumor type

Time to treatment failure, defined as time to change in systemic therapy or permanent discontinuation of cancer therapy

National Cancer Institute (NCI)

University of California, Davis

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Carcinoma

Carcinoma, Renal Cell

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Transitional Cell Carcinoma

Mamta Parikh, MD, MS

Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)

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

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

Principal Investigator

Digestive System Diseases

Esophageal Neoplasms

Cholangiocarcinoma

Stomach Neoplasms

Urinary Bladder Neoplasms

Gallbladder Neoplasms

Appendiceal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Biliary Tract Neoplasms

Biliary Tract Diseases

Gallbladder Diseases

Cecal Neoplasms

Cecal Diseases

Esophageal Cancer

Bile Duct Cancer

Stomach Cancer

Biliary Tract Cancer

Gallbladder Cancer

Intrahepatic Cholangiocarcinoma

Small Intestine Cancer

Selina Laqui, MD, PhD

Edward Kim, MD, PhD

Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Small Cell Lung Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Megan Daly, MD

LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)	NCT06103669	Breast Cancer Oligoprogressiv... Head and Neck C... Sarcoma Other Cancer	Ablative local ...	18 Years -	University of California, Davis
Locally Ablative TherapY in Oligo-ProgressiVe GEnitourinary TumoRs (LAYOVER)	NCT06101290	Prostate Cancer Oligoprogressiv... Urothelial Carc... Renal Cell Carc...	Ablative local ...	18 Years -	University of California, Davis
Locally ablatiVe therApy in oLigO-pRogressive sOlid tUmorS (VALOROUS)	NCT06103669	Breast Cancer Oligoprogressiv... Head and Neck C... Sarcoma Other Cancer	Ablative local ...	18 Years -	University of California, Davis
Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)	NCT06101277	Esophageal Canc... Small Bowel Can... Gastroesophagea... Gastric Cancer Colorectal Canc... Appendiceal Can... Biliary Cancer Gall Bladder Ca... Intrahepatic Ch... Extrahepatic Ch... Oligoprogressiv...	Ablative local ...	18 Years -	University of California, Davis
LOcally ABLatIve ThErapy for OligopRogressive Lung And Thoracic MalignanciEs (OBLITERATE)	NCT06103682	Non-small Cell ... Oligoprogressiv... Small-cell Lung...	Ablative local ...	18 Years -	University of California, Davis

Spots Global Cancer Trial Database for ablative local therapy