Clinical trial NCT05130073: 4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-11-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with invasive SCCA

Brief 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.

Detailed 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 criteria: 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Benny Johnson
role: PRINCIPAL_INVESTIGATOR
References: