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Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers

Primary Purpose

Cancer of the Cervix, Vulvar Cancer, Esophageal Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FDG PET scan
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer of the Cervix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically (histologically or cytologically) proven diagnosis of cervical, vulvar, esophageal and anal canal cancer

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

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

Positive serum pregnancy test

Sites / Locations

  • Duke University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm interventional study

Arm Description

Research FDG-PET scan obtained before radiation therapy; a second research FDG-PET scan is obtained at about 3-5 weeks after treatment has started.

Outcomes

Primary Outcome Measures

The number of subjects with benefit from an intra-treatment PET-CT
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
Pathologic complete response
Pathologic complete response will be collected from pathology reports for subjects who have surgical resection after radiation therapy.
Locoregional control
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
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.
Measure overall survival (OS)
Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site
Progression free survival (PFS)
Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care for each disease site

Secondary Outcome Measures

Measure the potential sparing of radiation dose to critical normal tissue
An intra-treatment PET volume adaptive treatment plan may allow for additional sparing of normal tissue by identifying regions of tumor response and corresponding reduction in the target volumes i.e. dosimetric differences in normal tissue will be compared between the initial plan and the adapted plan.

Full Information

First Posted
January 11, 2018
Last Updated
September 14, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT03403465
Brief Title
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers
Official Title
Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers ( Adaptive PET II)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study expands on protocol (NCT01908504"PET adaptive RT") designed to evaluate the utility of adaptive PET-CT planning for radiation therapy (RT). Radiation therapy is used in many malignant diseases as a curative treatment modality. However, critical normal tissue is often in close approximation to disease, and portions of such tissue must receive high doses of radiation for appropriate treatment. Positron Emission Tomography (PET) adapted radiation therapy, as defined in the current protocol, may allow for a means of determining the eventual response to therapy, at a time point when adaptation of treatment plan may be possible to improve outcomes. This protocol will build upon the findings the previous protocol (NCT01908504 "PET adaptive RT") that evaluated the utility of intra-treatment PET imaging in multiple types of cancers. The current focus will be more specific to certain types of gastrointestinal and gynecologic cancers treated with RT, identified from the prior study to warrant further research.
Detailed Description
Intra-treatment PETs have only recently been studied in small pilot series. In rectal cancer, a prospective trial from MSKCC demonstrated that a PET-CT obtained in the second week of neoadjuvant chemoradiotherapy was able to discriminate sub-optimal responders with a sensitivity of 94% and an accuracy of 78%, though the most useful metric was a novel "visual response score" based on interpreting radiologists scoring rather than more established objective data available from PET, like SUV. A study from China in non-small cell lung cancer found that decreases in SUV and MTV on intra-treatment PET-CTs after 40Gy of chemoradiation therapy were significantly greater in patients responding to treatment by post-treatment RECIST criteria. For head and neck cancers, a Belgian study found that intra-treatment SUVmax at 47Gy was associated with significant differences in overall survival. Therefore, there is emerging evidence that an intra-treatment PET may also be of significant prognostic utility, at an early enough time point to potentially alter treatment accordingly. All participants will be required to complete two research PET scans in addition to standard of care planning CT's for radiation therapy. For all subjects with cancer of the cervix and vulva an intra-treatment PET-CT will be obtained and used to develop a volume adaptive treatment plan for the remainder of the course. Subjects with esophageal and anal canal cancer will have an adapted plan if the treating radiation oncologist determines an adapted plan is clinically relevant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Cervix, Vulvar Cancer, Esophageal Cancer, Anal Canal Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm interventional study
Arm Type
Other
Arm Description
Research FDG-PET scan obtained before radiation therapy; a second research FDG-PET scan is obtained at about 3-5 weeks after treatment has started.
Intervention Type
Other
Intervention Name(s)
FDG PET scan
Other Intervention Name(s)
PET scan
Intervention Description
At radiation planning subjects will have a PET-CT. The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.
Primary Outcome Measure Information:
Title
The number of subjects with benefit from an intra-treatment PET-CT
Description
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
Time Frame
4 years
Title
Pathologic complete response
Description
Pathologic complete response will be collected from pathology reports for subjects who have surgical resection after radiation therapy.
Time Frame
4 years
Title
Locoregional control
Description
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.
Time Frame
Day of intra treatment PET-CT/ approx 2-4 hours
Title
Freedom from distant metastases
Description
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.
Time Frame
4 years
Title
Measure overall survival (OS)
Description
Subjects will be evaluated in regular follow up with the investigators according to the standard of care for each disease site
Time Frame
4 years
Title
Progression free survival (PFS)
Description
Subjects will be evaluated in regular follow up with repeat imaging as per the standard of care for each disease site
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Measure the potential sparing of radiation dose to critical normal tissue
Description
An intra-treatment PET volume adaptive treatment plan may allow for additional sparing of normal tissue by identifying regions of tumor response and corresponding reduction in the target volumes i.e. dosimetric differences in normal tissue will be compared between the initial plan and the adapted plan.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically (histologically or cytologically) proven diagnosis of cervical, vulvar, esophageal and anal canal cancer 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 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 Positive serum pregnancy test
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Duffy, RN BSN
Phone
919 668 3726
Email
eileen.duffy@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junzo Chino, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eileen Duffy, RN BSN
Phone
919-668-3726
Email
Eileen.Duffy@duke.edu
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office
Phone
919 668 3726

12. IPD Sharing Statement

Plan to Share IPD
No

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Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers

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