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

Completed

• Conditions: Anal Squamous Cell Carcinoma; Stage IIB Anal Cancer AJCC v8; Stage IIIC Anal Cancer AJCC v8; Stage IIA Anal Cancer AJCC v8; Stage IIIB Anal Cancer AJCC v8; Stage I Anal Cancer AJCC v8; Stage III Anal Cancer AJCC v8; Stage 0 Anal Cancer AJCC v8; Stage II Anal Cancer AJCC v8; Stage IIIA Anal Cancer AJCC v8
• Interventions: Procedure: Computed Tomography; Other: Electronic Health Record Review; Procedure: Follow-Up; Procedure: Positron Emission Tomography

• Registration Number: NCT05130073
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-31
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2021-11-10
• Study First Posted: 2021-11-22
• Status Verified: 2023-12
• Primary Completion: 2023-12-14
• Study Completion: 2023-12-14
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (PET/CT, medical data review, follow-up)	Computed Tomography	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.
Observational (PET/CT, medical data review, follow-up)	Follow-Up	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.
Observational (PET/CT, medical data review, follow-up)	Positron Emission Tomography	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.
Observational (PET/CT, medical data review, follow-up)	Electronic Health Record Review	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.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States