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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

Must not have

Uncontrolled symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by any device or medication at the time of Step 1 registration

Cervical esophageal cancers arisen from 15-18 cm from the incisors

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

No Placebo-Only Group

Pivotal Trial

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.

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.

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

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I had a scan after my initial chemotherapy.

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

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

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

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I finished my initial chemotherapy less than 30 days ago.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled heart issues like failure, chest pain, or irregular heartbeat.

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My esophageal cancer is located 15-18 cm from my teeth.

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I do not have an active infection needing IV antibiotics.

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I haven't had any cancer within 2 years that could affect my esophageal cancer treatment.

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I have had chest radiation that would overlap with new treatment areas.

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My cancer has spread to other parts of my body.

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I can't get insurance or other payment for possible radiation treatment.

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My cancer is at stage T4b according to the latest standards.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Overall survival (OS)

Secondary study objectives

Cost-benefit economic analysis of treatment

Distant metastatic-free survival (DMFS)

Grade 4 lymphopenia during chemoradiation

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Paclitaxel

2011

Completed Phase 4

~5450

Proton Beam Radiation Therapy

2013

Completed Phase 2

~110