4-Point Therapy Response Score With PET/CT for Anal Squamous Cell Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVE:
- 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:
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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).
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To determine and validate inter-reader reliability. III. To calculate C-index to evaluate the prognostic capacity of PET/CT scores for survival.
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To determine the association between pre-treatment PET/CT scores after treatment and OS.
EXPLORATORY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational (PET/CT, medical data review, follow-up) 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. |
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
Other: Electronic Health Record Review
Review of medical records
Procedure: Follow-Up
Undergo follow-up
Other Names:
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Overall survival (OS) [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Age > 18 years at time of study entry
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Ability to provide written informed consent
Exclusion Criteria:
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Patients unwilling to participate in a PET/CT at baseline and at 3 months post completion of definitive chemoradiation
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Patients with an active second primary malignancy requiring chemotherapy or radiation treatment
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Stage IV SCCA
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Benny Johnson, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- PA19-0088
- NCI-2021-10964
- PA19-0088