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

Gastroesophageal Junction Adenocarcinoma Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

PRIMARY OBJECTIVE:

I. To determine the recommended phase II dose (RP2D) of hafnium oxide-containing nanoparticles NBTXR3 (NBTXR3) activated by radiotherapy with concurrent chemotherapy, per standard of care, for treatment naive patients with adenocarcinoma of the esophagus.

SECONDARY OBJECTIVES:

I. To evaluate the safety and feasibility of radiation with NBTXR3 in patients with adenocarcinoma of the esophagus.

II. To evaluate the anti-tumor response of chemoradiation with NBTXR3 in patients with adenocarcinoma of the esophagus.

III. To evaluate time-to-event outcomes after chemoradiation with NBTXR3 in patients with adenocarcinoma of the esophagus.

EXPLORATORY OBJECTIVES:

I. To evaluate the body kinetic profile of intratumorally/intranodally injected NBTXR3.

II. To evaluate time to event outcomes for patients with clinical staging of locally advanced, unresectable disease.

III. To evaluate surgical outcomes in patients who undergo surgery after study treatment.

IV. To evaluate radiomic measurements with outcomes. V. To assess immune-related biomarkers of response.

OUTLINE: This is a dose-escalation study of NBTXR3.

Patients receive NBTXR3 intratumorally (IT) or intranodally (IN) on day 1. Beginning day 15, patients undergo intensity-modulated radiation therapy (IMRT) 5 days per week for 6 weeks for a total of 28 fractions in the absence of disease progression or unacceptable toxicity. Beginning on day 15, concurrent with IMRT, patients receive a chemotherapy regimen consisting of either fluorouracil and oxaliplatin with or without leucovorin, oxaliplatin and capecitabine, docetaxel and fluorouracil with or without leucovorin, docetaxel and paclitaxel, or carboplatin and paclitaxel per physician discretion.

After completion of study treatment, patients are followed up every 3 months for 1 year. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Cervical Esophagus Adenocarcinoma
• Clinical Stage II Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
• Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8
• Clinical Stage III Esophageal Adenocarcinoma AJCC v8
• Esophageal Neoplasms
• Gastroesophageal Junction Adenocarcinoma
• Pathologic Stage II Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage III Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8
• Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8
• Thoracic Esophagus Adenocarcinoma

• NCT number: NCT04615013
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Recruiting
• Phase: Phase 1
• Start date: November 23, 2020
• Completion date: October 31, 2025