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Chemotherapy

Radiotherapy + Chemotherapy for Esophageal Cancer (PHOX Trial)

Phase 2

Recruiting

Led By Christopher L. Hallemeier, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Histological confirmation of esophageal or gastroesophageal junction adenocarcinoma, American Joint Committee on Cancer (AJCC) 8th edition stage T1-4N0-3M0

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 weeks after completion of chemoradiation

Awards & highlights

PHOX Trial Summary

This trial tests pre-surgery radiation w/ drugs to kill esophageal cancer cells & reduce side effects.

Who is the study for?

This trial is for adults with stage I-III esophageal or gastroesophageal junction adenocarcinoma confirmed by biopsy, who are fit for surgery and have not had prior chemo or radiotherapy to the chest. Participants must be able to consent, complete questionnaires, provide blood samples for research, and use effective contraception if of childbearing potential.Check my eligibility

What is being tested?

The study tests preoperative hypofractionated radiation therapy combined with FOLFOX (fluorouracil, oxaliplatin, leucovorin calcium) in treating esophageal cancer. The goal is to see if this approach kills more tumor cells before surgery compared to standard treatments.See study design

What are the potential side effects?

Potential side effects include skin reactions from radiation, fatigue from chemotherapy drugs like fluorouracil and oxaliplatin, possible nerve damage from oxaliplatin known as neuropathy, digestive issues such as nausea or diarrhea, and a risk of low blood cell counts leading to infections.

PHOX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is confirmed as esophageal or gastroesophageal junction adenocarcinoma, at a specific stage.

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A surgeon has approved me for esophagus surgery.

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I am fully active or can carry out light work.

PHOX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 weeks after completion of chemoradiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 weeks after completion of chemoradiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks after completion of chemoradiation for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Pathologic complete response

Secondary outcome measures

Event free survival

Financial toxicity

Incidence of acute ≥ gastrointestinal (GI) adverse events (AEs)

+8 more

PHOX Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (Radiation and FOLFOX)Experimental Treatment10 Interventions

Patients receive oxaliplatin IV over 2-6 hours on day 1, leucovorin calcium IV over 10-120 minutes on day 1, and and fluorouracil IV over 46-48 hours on days 1 and 2. Treatment repeats every 2 weeks for a total of 3 cycles in the absence of disease progression or unacceptable toxicity. Starting at cycle 2, patients undergo radiation therapy daily on Monday through Friday for a total of 15 treatments. Patients undergo EGD and/or EUS during screening and undergo CT/PET scan and CT scan as well as blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionated Radiation Therapy

2016

Completed Phase 2

~130

Esophagogastroduodenoscopy

2017

Completed Phase 3

~980

Fluorouracil

2014

Completed Phase 3

~11540

Endoscopic Ultrasound

2010

Completed Phase 2

~350

Oxaliplatin

2011

Completed Phase 4

~2560

Leucovorin Calcium

2011

Completed Phase 3

~12310

Positron Emission Tomography

2008

Completed Phase 2

~2240

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,670 Previous Clinical Trials

40,926,337 Total Patients Enrolled

Mayo ClinicLead Sponsor

3,216 Previous Clinical Trials

3,767,189 Total Patients Enrolled

Christopher L. Hallemeier, M.D.Principal InvestigatorMayo Clinic in Rochester

Frequently Asked Questions

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

Is this trial taking on new participants at the present moment?

"As indicated on the clinicaltrials.gov portal, this medical trial is no longer actively recruiting participants for enrollment. Initially posted October 31st 2023 and last updated on October 9th 2023, there are however a multitude of other studies currently in search for individuals to join their trials."

Answered by AI

Does the FDA sanction radiation and FOLFOX as viable treatments?

"Our team at Power evaluates the safety of this particular treatment regimen (Radiation and FOLFOX) as a 2 due to it being in Phase 2 trials, meaning there is evidence supporting its security but no data for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

2023. "Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06078709.