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Completed

NCT Number: NCT05130073

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computed Tomography

Procedure

Undergo PET/CT

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Electronic Health Record Review

Other

Review of medical records

Follow-Up

Procedure

Undergo follow-up

Other names: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup

Positron Emission Tomography

Procedure

Undergo PET/CT

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Primary outcomes

  1. Overall survival (OS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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