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Radiosensitizer

Hypoxia-Guided Radiation for Esophageal Cancer (PIONEER Trial)

Phase 1
Recruiting
Led By Randa Tao, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Esophageal cancer patient eligible to undergo either neoadjuvant or definitive CRT
ECOG Performance Status ≤ 2
Must not have
The subject has severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for chemoradiation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after last study therapy
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a higher dose of radiation therapy, based on levels of tumor hypoxia, is safe.

Who is the study for?
This trial is for adults with esophageal cancer who can undergo chemoradiation therapy (CRT). They should be able to consent, have an ECOG Performance Status ≤ 2, and may include Stage IV patients with limited metastases if CRT is advised. Women must not be pregnant or must be post-menopausal.
What is being tested?
The trial tests personalized radiation therapy guided by hypoxia levels in tumors identified using FMISO PET CT and MRI scans. Patients with hypoxic tumors will receive higher radiation doses while others follow standard care. An interim MRI determines further treatment adjustments.
What are the potential side effects?
Potential side effects include those typically associated with radiation therapy such as skin irritation, fatigue, difficulty swallowing, nausea, and potential increased risk of secondary cancers long-term. Specific side effects from the imaging agents used could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am eligible for initial or main treatment before surgery for esophageal cancer.
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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that would prevent me from receiving chemoradiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after last study therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after last study therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 5.0), seriousness, duration, and relationship to study treatment
rate of grade ≥ 4 esophageal adverse events attributed to radiation therapy that occur within 30 days of finishing radiation therapy
rate of grade ≥ 4 esophageal adverse events attributed to radiation therapy that occur within 84 days of finishing radiation therapy
Secondary study objectives
Pathological complete response (pCR) rate
Progression-free survival (PFS)

Side effects data

From 2022 Phase 2 trial • 26 Patients • NCT03043807
81%
fatigue
38%
hot flashes
38%
neuropathy
19%
alopecia;
19%
dysgeusia
15%
hiccups
15%
nausea
15%
skin alterations
12%
diarrhea
12%
gastritis
12%
edema (lower extremity)
12%
rash
12%
constipation
8%
anxiety
8%
xerosis
4%
elevated AST
4%
elevated ALT
4%
hematochezia
4%
cough
4%
xerostomia
4%
general body aches
4%
pruritis
4%
nail discoloration
4%
fever
4%
anemia
4%
epistaxis
4%
infusion related reaction
4%
neutropenia
4%
neutropenic fever
4%
gastrointestinal reflux
4%
pain (bilateral legs)
4%
mucositis
4%
pain (joint);
4%
anorexia
4%
nail ridging
4%
weight gain
4%
hematuria
4%
urinary tract obstruction
4%
oral candidiasis
4%
insomnia
4%
depression
4%
dyspnea
4%
arthritis
4%
pain (pelvis)
4%
memory impairment
4%
heartburn
100%
80%
60%
40%
20%
0%
Study treatment Arm
Chemohormonal and Definitive Therapy After Prostatectomy

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: Treatment: all patientsExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation
2003
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,064 Total Patients Enrolled
Randa Tao, MDPrincipal InvestigatorHuntsman Cancer Institute
Shane Lloyd, MDPrincipal InvestigatorHuntsman Cancer Institute

Media Library

FMISO PET CT (Radiosensitizer) Clinical Trial Eligibility Overview. Trial Name: NCT04846309 — Phase 1
Esophageal Cancer Research Study Groups: Treatment: all patients
Esophageal Cancer Clinical Trial 2023: FMISO PET CT Highlights & Side Effects. Trial Name: NCT04846309 — Phase 1
FMISO PET CT (Radiosensitizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04846309 — Phase 1
~1 spots leftby Apr 2025
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