← Back to Search

Photon Radiotherapy

Proton Therapy vs Photon Radiation for Esophageal Cancer

Phase 3

Recruiting

Led By Steven Lin

Research Sponsored by NRG Oncology

Eligibility Criteria Checklist

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

Must have

For patients who DID receive induction chemotherapy, scan must occur:

Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without (+/-) contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization to the date of death due to any cause or date of last follow-up for patients without an os event reported. this analysis occurs after 173 deaths; estimated to occur 4 years after accrual completion

Awards & highlights

Study Summary

This trial compares proton beam radiation therapy with intensity modulated photon radiotherapy in treating patients with esophageal cancer.

Who is the study for?

This trial is for adults with stage I-IVA esophageal cancer, either adenocarcinoma or squamous cell carcinoma. They should not have metastatic disease, prior thoracic radiotherapy overlapping the treatment area, uncontrolled infections or heart conditions, and must not be pregnant. Eligible participants need a certain blood count level and organ function within normal ranges.Check my eligibility

What is being tested?

The study compares proton beam radiation therapy to intensity-modulated photon radiotherapy in treating esophageal cancer. Proton therapy uses protons to target the tumor with minimal damage to surrounding tissue; photon therapy uses high-energy x-rays similarly focused.See study design

What are the potential side effects?

Potential side effects include skin reactions at the treatment site, fatigue, difficulty swallowing due to inflammation of the esophagus (esophagitis), nausea, potential lung issues like pneumonitis, and other typical radiation-related symptoms.

Eligibility Criteria

Inclusion Criteria

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

Select...

I had a scan after my initial chemotherapy.

Select...

I have had a PET/CT scan or a CT scan of my chest and abdomen.

Select...

I can take care of myself and am up and about more than 50% of my waking hours.

Select...

I had a procedure to remove early-stage esophageal cancer but it wasn't the most advanced type.

Select...

I finished my initial chemotherapy less than 30 days ago.

Select...

My cancer is confirmed to be in the esophagus or where my stomach meets my esophagus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization to the date of death due to any cause or date of last follow-up for patients without an os event reported. this analysis occurs after 173 deaths; estimated to occur 4 years after accrual completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization to the date of death due to any cause or date of last follow-up for patients without an os event reported. this analysis occurs after 173 deaths; estimated to occur 4 years after accrual completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization to the date of death due to any cause or date of last follow-up for patients without an os event reported. this analysis occurs after 173 deaths; estimated to occur 4 years after accrual completion for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of specific grade 3+ cardiopulmonary adverse events (AEs) that are definitely, probably, or possibly related to protocol treatment

Overall survival (OS)

Secondary outcome measures

Cost-benefit economic analysis of treatment

Distant metastatic-free survival (DMFS)

Grade 4 lymphopenia during chemoradiation

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (PBT, Chemotherapy, Esophagectomy)Experimental Treatment10 Interventions

Patients undergo PBT over 28 fractions 5 days a week for 5.5 weeks to a total dose of 50.4 Gy. Patients also receive chemotherapy (Choice of 3 regimens: 1. Carboplatin/Paclitaxel, 2. FOLFOX/CAPOX or 3. Docetaxel/5-FU [with capecitabine as an acceptable substitute for 5-FU]) per institutional standards while undergoing PBT. Within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion.

Group II: Group II (IMRT, Chemotherapy, Esophagectomy)Active Control10 Interventions

Patients undergo IMRT over 28 fractions 5 days a week for 5.5 weeks to a total dose of 50.4 Gy. Patients also receive chemotherapy (Choice of 3 regimens: 1. Carboplatin/Paclitaxel, 2. FOLFOX/CAPOX or 3. Docetaxel/5-FU [with capecitabine as an acceptable substitute for 5-FU]) per institutional standards while undergoing IMRT. Within 4-8 weeks after completion of chemotherapy and radiation therapy, patients may undergo an esophagectomy per physician discretion.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

5FU

2016

Completed Phase 3

~250

FOLFOX regimen

2009

Completed Phase 3

~2440

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110

Docetaxel

1995

Completed Phase 4

~5620

Paclitaxel

2011

Completed Phase 4

~5380

Carboplatin

2014

Completed Phase 3

~6670

Esophagectomy

2016

Completed Phase 3

~4130

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

NRG OncologyLead Sponsor

231 Previous Clinical Trials

100,552 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,664 Previous Clinical Trials

40,925,833 Total Patients Enrolled

Steven LinPrincipal InvestigatorNRG Oncology

1 Previous Clinical Trials

3 Total Patients Enrolled

Media Library

Intensity-Modulated Radiation Therapy (Photon Radiotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03801876 — Phase 3

Gastroesophageal Junction Adenocarcinoma Research Study Groups: Group I (PBT, Chemotherapy, Esophagectomy), Group II (IMRT, Chemotherapy, Esophagectomy)

Gastroesophageal Junction Adenocarcinoma Clinical Trial 2023: Intensity-Modulated Radiation Therapy Highlights & Side Effects. Trial Name: NCT03801876 — Phase 3

Intensity-Modulated Radiation Therapy (Photon Radiotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03801876 — Phase 3

Frequently Asked Questions

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

What are some of the most common reasons why a doctor would recommend Esophagectomy?

"Esophagectomy, while commonly used to treat actinic keratosis, can also help patients manage neoplasm metastasis, lymphoma, non-hodgkin's anxiety."

Answered by AI

How many research sites are participating in this investigation?

"This particular clinical trial is being conducted at UHHS-Westlake Medical Center, University of Oklahoma Health Sciences Center, and University Hospitals Parma Medical Center. However, there are 65 other research sites where this experiment is also taking place."

Answered by AI

How many patients are receiving care through this research project?

"In order to start this study, the sponsor requires that 300 potential patients meet the specified inclusion criteria and enroll. University of Oklahoma Health Sciences Center in Oklahoma City and UHHS-Westlake Medical Center in Westlake, Texas are two of the sites where participants can be recruited from."

Answered by AI

Are there any current vacancies for participants in this research?

"That is correct, the website provides evidence that this research study is recruiting. The trial was posted on March 15th, 2019 and updated last November 14th, 2022. They are looking for 300 volunteers spread out over 65 hospitals or locations."

Answered by AI

Has the FDA given their stamp of approval to Esophagectomy?

"Esophagectomy has received a safety score of 3 from our team at Power. This is because Phase 3 trials have both some evidence of efficacy and multiple rounds of data supporting safety."

Answered by AI

Are there any ongoing or previous research studies that have explored Esophagectomy?

"Esophagectomy was first performed as a medical procedure in 1997 at City of Hope Comprehensive Cancer Center. As of right now, there have been 2949 completed clinical trials studying this topic. Additionally, there are currently 1687 active studies being conducted; many of these trials taking place in Westlake, Oklahoma."

Answered by AI

What benefits does this clinical trial hope to bring patients?

"The primary goal for this clinical trial is to measure the incidence of specific grade 3+ cardiopulmonary adverse events (AEs) that are definitely, probably, or possibly related to protocol treatment. This analysis occurs after 173 deaths; estimated to occur 4 years after accrual completion. Secondary outcomes for this study include Locoregional failure (LRF), Progression-free survival (PFS), and Quality-adjusted life years (QALY)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

2019. "Comparing Proton Therapy to Photon Radiation Therapy for Esophageal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03801876.

All > Esophagus Cancer > Esophageal Cancer