Spots Global Cancer Trial Database for Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor
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Trial Identification
Brief Title: Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor
Official Title: External Beam Radiation to Eliminate Nominal Metastatic Disease (EXTEND): A Randomized Phase II Basket Trial Assessing the Efficacy of Upfront Local Consolidative Therapy (LCT) for Oligometastatic Disease
Study ID: NCT03599765
Conditions
Study Description
Brief Summary: This phase II trial studies how well systemic therapy with or without local consolidative therapy work in treating patients with solid tumor that has spread to 1 site of other places in the body. Treatment with up-front local consolidative therapy may be better in helping to control the disease.
Detailed Description: PRIMARY OBJECTIVES: I. In patients with oligometastatic malignancies, to assess progression free survival (PFS) with upfront local consolidative therapy (LCT) versus (vs.) no LCT among randomized patients. SECONDARY OBJECTIVES: I. In patients with oligometastatic malignancies, to assess overall survival (OS) with upfront LCT vs. no LCT among randomized patients. II. In patients with oligometastatic malignancies, to assess time to next line systemic therapy with upfront LCT vs. no LCT. III. In patients with oligometastatic malignancies, to assess time to new lesion failure with upfront LCT vs. no LCT. IV. To assess safety/tolerability of upfront LCT in patients with oligometastatic malignancies. V. In patients with oligometastatic malignancies, to assess quality of life with upfront LCT vs. no LCT. EXPLORATORY OBJECTIVES: I. To identify predictive/prognostic biomarkers that are associated with a benefit to LCT across disease sites. II. To investigate the systemic immune activating effects of radiation. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive up-front standard of care LCT including but not limited to surgical resection, cryotherapy, and radiofrequency ablation. Patients then receive routine drug therapy. ARM II: Patients receive routine drug therapy. Patients may later receive LCT at the discretion of doctor. After completion of study, patients are followed up every 18 weeks.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
Baptist Health Medical Center, Little Rock, Arkansas, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Community Health Center, Coldwater, Michigan, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
OhioHealth Mansfield Hospital, Mansfield, Ohio, United States
M D Anderson Cancer Center, Houston, Texas, United States
MD Anderson in Katy, Houston, Texas, United States
MD Anderson League City, Nassau Bay, Texas, United States
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
MD Anderson in Sugar Land, Sugar Land, Texas, United States
MD Anderson in The Woodlands, The Woodlands, Texas, United States
Contact Details
Name: Chad Tang
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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