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

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

Recruiting
18 years and older
All
Phase N/A

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.

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.

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 details
    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

NCT05130073

M.D. Anderson Cancer Center

14 March 2022

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