Trials / Completed
CompletedNCT05130073
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 41 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Computed Tomography | Undergo PET/CT |
| OTHER | Electronic Health Record Review | Review of medical records |
| PROCEDURE | Follow-Up | Undergo follow-up |
| PROCEDURE | Positron Emission Tomography | Undergo PET/CT |
Timeline
- Start date
- 2019-07-31
- Primary completion
- 2023-12-14
- Completion
- 2023-12-14
- First posted
- 2021-11-22
- Last updated
- 2024-02-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05130073. Inclusion in this directory is not an endorsement.