Adaptive Pet Study

Not Applicable

Completed

• Conditions: Head and Neck Cancers; Lung and Esophagus Cancers; Anal, Cervix, Vulvar, Vaginal, and Endometrium Cancers
• Interventions: Other: PET-CT

• Registration Number: NCT01908504
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to determine the benefit of using positron emission tomography (PET) in addition to the standard (computed tomography) CT to plan radiation therapy for cancer treatment. The information from the PET-CT may allow the investigators to change the radiation plan or the delivery of the radiation to the tumor/tumor site such as the total dose of radiation or the size of the area to receive further radiation. Presently the use of PET scans to adjust radiation therapy during radiation treatment is not standard of care and is being investigated in this study.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2013-07-19
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-25
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2019-05
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

Inclusion Criteria

• Pathologically (histologically or cytologically) proven diagnosis of carcinoma
• Patients with local or regional nodal disease are eligible.
• Zubrod Performance Status 0, 1, or 2.
• Age ≥ 18
• Negative serum pregnancy test for women of child bearing potential
• Patient must sign study-specific informed consent prior to study entry.

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Exclusion Criteria

• No gross disease visible on imaging at the start of radiotherapy
• Contraindication to PET
• Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
• Breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET-CT	PET-CT	-

Primary Outcome Measures

Name	Time	Method
The number of subjects with benefit from an intra-treatment PET-CT	3 years	This benefit lies in the potential to adapt the treatment plan based on an intratreatment PET-CT. This may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly.

Secondary Outcome Measures

Name	Time	Method
Measure overall survival (OS)	3 years	Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site.
Measure late toxicities	3 years	Subjects will be evaluated in regular follow up with measures of treatment related side effects.
Measure acute toxicities	During radiation therapy and within 30 days of the last radiation treatment	Acute toxicity will be assessed weekly as per the standard practice of the treating investigator.
Locoregional control.	Day of intra treatment PET-CT/ approx 2-4 hours	This study will evaluate the prognostic value of intra-treatment functional imaging on clinical relevant tumor endpoints (i.e. locoregional control, freedom from distant metastases, and overall survival).Comparison of intra-treatment FDG-PET indices will identify two groups of responses: PET responses and PET non-responses, which will correlate with prognosis.
Freedom from distant metastases	3 years	Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care, or at the treating investigator's discretion. Frequency of follow up will be determined by the standard practice for the disease site and stage.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States