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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom from distant metastases

Locoregional control

Measure overall survival (OS)

+3 more

Secondary outcome measures

Body tissue

Side effects data

From 2008 Phase 2 trial • 20 Patients • NCT00350142

15%

ulcer

10%

vomiting

Perforation

pain

100%

80%

60%

40%

20%

Study treatment Arm

SBRT With Gem

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,356 Total Patients Enrolled

Junzo Chino, MDPrincipal InvestigatorDuke University

4 Previous Clinical Trials

312 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available in this clinical trial for participants?

"As seen on clinicaltrials.gov, this medical trial is accepting patients and has been in operation since March 27th 2018 with the most recent update being November 15th 2022."

Answered by AI

Does this therapeutic intervention have the endorsement of the FDA?

"Our team has rated this treatment's safety as a 2, since no efficacy data exists yet but some information suggests that it is safe for patients."

Answered by AI

How many participants are taking part in this clinical research project?

"Affirmative. On clinicaltrials.gov, we can observe that this medical experiment is actively enrolling individuals. It was first posted on March 27th 2018 and last updated on November 15th 2022; the researchers are attempting to recruit 130 people from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Intratreatment FDG-PET During Radiation Therapy for Gynecologic and Gastrointestinal Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03403465.

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