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NCT05130073 Clinical Trial

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

Anal Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05130073
Other study ID # PA19-0088
Secondary ID NCI-2021-10964PA
Status Completed
Phase
First received
Last updated
Start date July 31, 2019
Est. completion date December 14, 2023

Study information
Verified date December 2023
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 41
Est. completion date December 14, 2023
Est. primary completion date December 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Computed Tomography
Undergo PET/CT
Other:
• Electronic Health Record Review
Review of medical records
Procedure:
• Follow-Up
Undergo follow-up
• Positron Emission Tomography
Undergo PET/CT

Locations
Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (2)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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