4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer

M.D. Anderson Cancer Center41 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Anal Squamous Cell Carcinoma Stage 0 Anal Cancer AJCC v8 Stage I Anal Cancer AJCC v8

Interventions

Computed TomographyPROCEDURE

Undergo PET/CT

Electronic Health Record ReviewOTHER

Review of medical records

Follow-UpPROCEDURE

Undergo follow-up

Positron Emission TomographyPROCEDURE

Undergo PET/CT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed biopsy proven invasive SCCA (any T, any N) deemed a candidate to undergo standard of care definitive chemoradiation at MD Anderson Cancer Center (MDACC) with curative intent * Age \> 18 years at time of study entry * Ability to provide written informed consent Exclusion Criteria: * Patients unwilling to participate in a PET/CT at baseline and at 3 months post completion of definitive chemoradiation * Patients with an active second primary malignancy requiring chemotherapy or radiation treatment * Stage IV SCCA

Outcomes

Primary Outcomes

Overall survival (OS)

The Kaplan-Meier method will be used. Log rank test will be used to compare OS between positron emission tomography (PET)/computed tomography (CT) negative and positive tumor group. Multivariable Cox proportional hazards models will be fitted to evaluate the association between OS and PET/CT scores, adjusting for the effects of covariates. In addition to positive and negative tumor groups, PET/CT scores of 4 categories will also be analyzed. C-index will be calculated to evaluate the prognostic capacity of PET/CT score with survival outcomes. Additionally, the Cohen kappa coefficient will be calculated to measure inter-reader agreement.

Time frame: Through study completion, an average of 1 year