- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05130073
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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.
|
Review of medical records
Undergo PET/CT
Other Names:
Undergo PET/CT
Other Names:
Undergo follow-up
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: Through study completion, an average of 1 year
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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.
|
Through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Benny Johnson, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Anus Diseases
- Carcinoma, Squamous Cell
- Neoplasms, Squamous Cell
- Anus Neoplasms
Other Study ID Numbers
- PA19-0088 (Other Identifier: M D Anderson Cancer Center)
- NCI-2021-10964 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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