Neoplasms

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Carcinoma, Squamous Cell

Anus Neoplasms

Neoplasms, Squamous Cell

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Rectal Neoplasms

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Gastrointestinal Neoplasms

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Gastrointestinal Diseases

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Rectal Diseases

Anal Cancer

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.

Computed Tomography

Electronic Health Record Review

Follow-Up

Positron Emission Tomography

Benny Johnson

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.

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.

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

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

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.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer	NCT05130073	Anal Squamous C... Stage 0 Anal Ca... Stage I Anal Ca... Stage II Anal C... Stage IIA Anal ... Stage IIB Anal ... Stage III Anal ... Stage IIIA Anal... Stage IIIB Anal... Stage IIIC Anal...	Computed Tomogr... Electronic Heal... Follow-Up Positron Emissi...	18 Years -	M.D. Anderson Cancer Center
4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer	NCT05130073	Anal Squamous C... Stage 0 Anal Ca... Stage I Anal Ca... Stage II Anal C... Stage IIA Anal ... Stage IIB Anal ... Stage III Anal ... Stage IIIA Anal... Stage IIIB Anal... Stage IIIC Anal...	Computed Tomogr... Electronic Heal... Follow-Up Positron Emissi...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for stage iiia anal cancer ajcc v8