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FDG-PET Guided Radiation for Gastrointestinal and Gynecologic Cancers

Phase 2
Recruiting
Led By Junzo Chino, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically (histologically or cytologically) proven diagnosis of cervical, vulvar, esophageal, and anal canal cancer
Zubrod Performance Status 0, 1, or 2
Must not have
Complete response by PET achieved with pre-radiation therapy treatment (surgery or chemotherapy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is researching whether PET scans can help doctors better target radiation therapy for cancer patients, specifically those with gastrointestinal or gynecologic cancers.

Who is the study for?
This trial is for adults over 18 with certain types of cancer (cervical, vulvar, esophageal, anal) who are not pregnant or breastfeeding. They must have a performance status indicating they can carry out daily activities with ease or with some limitation and visible disease on imaging before radiotherapy.
What is being tested?
The study tests if PET scans during radiation therapy can help adapt the treatment plan to improve outcomes for patients with specific gastrointestinal and gynecologic cancers. It builds upon previous research suggesting benefits of intra-treatment PET imaging.
What are the potential side effects?
While the trial focuses on using FDG-PET scans which generally have few side effects such as allergic reactions or discomfort at the injection site, radiation therapy may cause skin changes, fatigue, nausea, and other organ-specific side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer diagnosis is confirmed for cervical, vulvar, esophageal, or anal canal.
Select...
I can take care of myself and am up and about more than 50% of my waking hours.
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer responded completely to treatment before radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Freedom from distant metastases
Locoregional control
Measure overall survival (OS)
+3 more
Secondary study objectives
Body tissue

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00350142
15%
ulcer
10%
vomiting
5%
Perforation
5%
pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
SBRT With Gem

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm interventional studyExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,455 Previous Clinical Trials
2,971,422 Total Patients Enrolled
Junzo Chino, MDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
312 Total Patients Enrolled
~13 spots leftby Sep 2025
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