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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Role of a 4-point Therapy Response Score With PET/CT Post Definitive Chemoradiation for Anal Squamous Cell Cancer: A Prospective Study

Conditions
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Anal Squamous Cell Carcinoma, Stage 0 Anal Cancer AJCC v8, Stage I Anal Cancer AJCC v8, Stage II Anal Cancer AJCC v8, Stage IIA Anal Cancer AJCC v8, Stage IIB Anal Cancer AJCC v8, Stage III Anal Cancer AJCC v8, Stage IIIA Anal Cancer AJCC v8, Stage IIIB Anal Cancer AJCC v8, Stage IIIC Anal Cancer AJCC v8

Intervention / Treatment
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* Procedure: Computed Tomography
* Other: Electronic Health Record Review
* Procedure: Follow-Up
* Procedure: Positron Emission Tomography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (PET/CT, medical data review, follow-up)<br>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. | Procedure: Computed Tomography<br>* Undergo PET/CT<br>* Other names: tomography;Other: Electronic Health Record Review<br>* Review of medical records<br>Procedure: Follow-Up<br>* Undergo follow-up<br>* Other names: Followup;Procedure: Positron Emission Tomography<br>* Undergo PET/CT<br>* Other names: proton magnetic resonance spectroscopic imaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 1 year |