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Chemotherapy

Intense Radiation + Chemotherapy for Esophageal Cancer

Phase 1

Recruiting

Led By Shahed N Badiyan, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

At least 18 years of age.

Biopsy-proven carcinoma of the thoracic esophagus, or gastroesophageal junction (GEJ).

Must not have

Known brain metastases. Patients with known brain metastases must be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.

- Persistent complications from any major surgery within 4 weeks of study treatment start.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 6 month follow-up for all enrolled patients (estimated to be 65 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a more intense form of radiation therapy can improve outcomes for people with inoperable esophageal cancer.

Who is the study for?

This trial is for adults with inoperable esophageal cancer who can't have surgery. They should be able to handle chemoradiation, have a performance status showing they're relatively active (ECOG 0-2), and their blood counts and organ functions need to meet specific criteria. Pregnant or breastfeeding women can't join, nor can those with certain other health issues or recent major surgeries.

What is being tested?

The study tests if intensifying radiation therapy using an accelerated hypofractionated method along with chemotherapy drugs Carboplatin and Paclitaxel improves outcomes in patients with advanced esophageal cancer. It also includes various assessments like symptom inventories, quality of life questionnaires, social support measures, and optional blood tests for tumor DNA.

What are the potential side effects?

Potential side effects include reactions to the chemotherapy drugs such as nausea, hair loss, numbness in fingers or toes (neuropathy), low blood cell counts leading to increased infection risk or bleeding problems. The intensified radiation may cause more intense side effects at the site of treatment including pain or difficulty swallowing.

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 in the esophagus or where the stomach meets the esophagus.

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I am scheduled for IMRT photon beam therapy, not 3D CRT or proton therapy.

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I am eligible for and can undergo chemoradiation treatment.

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My esophageal cancer cannot be removed by surgery.

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My liver tests are within the normal range.

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My kidney function is within the normal range according to recent tests.

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My recent blood test shows my bone marrow is working well.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

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

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I do not have brain metastases.

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I have had no major surgery complications in the last 4 weeks.

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I have not had unstable angina or heart failure in the last 6 months.

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I do not have a severe lung condition that requires hospital care right now.

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I have a severe injury or hole in my esophagus.

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I have HIV but my CD4+ T-cell count is above 350 and I haven't had an AIDS-related infection in the last year.

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My cancer is a specific type of stomach cancer (Siewert-Stein Type III).

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I do not have severe nerve damage.

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I am planning to have or have already had initial chemotherapy.

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I am not on IV antibiotics for a bacterial or fungal infection.

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I had a major heart attack in the last 6 months.

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My cancer is located in the upper part of my esophagus.

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I have a serious heart rhythm problem that is not well controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 6 month follow-up for all enrolled patients (estimated to be 65 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 6 month follow-up for all enrolled patients (estimated to be 65 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 6 month follow-up for all enrolled patients (estimated to be 65 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose (MTD) of hypofractionated IMRT with chemotherapy

Secondary study objectives

Median local relapse-free survival

Median overall survival

Median progression-free survival

+5 more

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: IMRT + Carboplatin + PaclitaxelExperimental Treatment10 Interventions

Concurrent chemoradiation will consist of hypofractionated intensity modulated radiation therapy (IMRT) with simultaneous integrated boost (SIB) for 3 weeks with carboplatin and paclitaxel for 3 cycles every 7 days. Endoscopy and (optional) PET/CT within 6-8 weeks post-completion of chemoradiation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450