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Brief Title: 4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer
Official Title: The Role of a 4-point Therapy Response Score With PET/CT Post Definitive Chemoradiation for Anal Squamous Cell Cancer: A Prospective Study
Study ID: NCT05130073
Brief Summary: This study determines whether a positron emission tomography (PET)/computed tomography (CT) 4-point scoring system may predict overall survival for anal squamous cell cancer patients. A 4-point scoring system involving imaging scans may help to predict how patients with anal squamous cell cancer respond to chemoradiation therapy.
Detailed Description: PRIMARY OBJECTIVE: I. To determine whether a PET/CT scoring system in invasive biopsy proven anal squamous cell carcinoma (SCCA) to be treated with chemoradiation with curative intent (any T any N) predicts for overall survival (OS). SECONDARY OBJECTIVES: I. To determine whether a PET/CT scoring system in invasive biopsy proven SCCA to be treated with definitive chemoradiation with curative intent predicts for progression free survival (PFS). II. To determine and validate inter-reader reliability. III. To calculate C-index to evaluate the prognostic capacity of PET/CT scores for survival. IV. To determine the association between pre-treatment PET/CT scores after treatment and OS. EXPLORATORY OBJECTIVE: I. To correlate level of standardized uptake value (SUV) pre and post therapy and its correlation with overall survival. OUTLINE: Patients undergo PET/CT at baseline and at 3 months post therapy completion. Patients' medical records are received. Patients are followed up for 5 years.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
M D Anderson Cancer Center, Houston, Texas, United States
Name: Benny Johnson
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR