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

  • STATUS
    Recruiting
  • participants needed
    139
  • sponsor
    M.D. Anderson Cancer Center
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Updated on 14 March 2022
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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.

Details
Condition 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
Age 18years or above
Treatment Positron Emission Tomography, Computed Tomography, Electronic Health Record Review, Follow-Up
Clinical Study IdentifierNCT05130073
SponsorM.D. Anderson Cancer Center
Last Modified on14 March 2022

Eligibility

 Yes No Not Sure

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
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