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RecruitingPhase 1NCT04615013

NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer

A Phase 1 Study of NBTXR3 Activated by Radiotherapy With Concurrent Chemotherapy for Adenocarcinoma of the Esophagus

Sponsor

M.D. Anderson Cancer Center

Enrollment

24 participants

Start Date

Nov 23, 2020

Study Type

INTERVENTIONAL

Conditions

Gastroesophageal Junction AdenocarcinomaClinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Cervical Esophagus AdenocarcinomaClinical Stage IIA Esophageal Adenocarcinoma AJCC v8Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage II Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8Pathologic Stage III Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8Thoracic Esophagus Adenocarcinoma

Summary

The purpose of this Phase I study is to determine the recommended phase 2 dose (RP2D) and safety profile of NBTXR3 activated by radiation therapy with concurrent chemotherapy for the treatment of patients with esophageal adenocarcinoma. NBTXR3 is a drug that when activated by radiation therapy, may cause targeted destruction of cancer cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs, such as oxaliplatin, fluorouracil, capecitabine, docetaxel, paclitaxel, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NBTXR3 activated by radiation therapy with concurrent chemotherapy may help control the disease.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding NBTXR3 (tiny radioactive particles injected directly into the tumor) to standard chemoradiation therapy improves outcomes for people with esophageal cancer or cancer at the junction of the stomach and esophagus. **You may be eligible if...** - You have been confirmed by biopsy to have adenocarcinoma of the esophagus or gastroesophageal junction (stages II–III) - You are able to receive chemoradiation therapy - Your doctor determines the NBTXR3 injection can be safely delivered using an endoscopic ultrasound procedure - You have at least one measurable tumor site in the esophagus **You may NOT be eligible if...** - You cannot tolerate chemoradiation for medical reasons - Your tumor anatomy makes the injection technically impossible - You are pregnant or breastfeeding - You have significant kidney, liver, or blood count problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

Not applicable to this study

DRUGCarboplatin

Not applicable to this study

DRUGDocetaxel

Not applicable to this study

DRUGFluorouracil

Not applicable to this study

OTHERHafnium Oxide-containing Nanoparticles NBTXR3

Given IT or IN

RADIATIONIntensity-Modulated Radiation Therapy

Undergo IMRT

DRUGLeucovorin

Not applicable to this study

DRUGOxaliplatin

Not applicable to this study

DRUGPaclitaxel

Not applicable to this study

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04615013

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