Health Trials

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

ConditionsCervical Esophagus AdenocarcinomaClinical Stage II Esophageal Adenocarcinoma AJCC v8Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8Clinical Stage III Esophageal Adenocarcinoma AJCC v8Gastroesophageal Junction AdenocarcinomaPathologic 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
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

Qualifiers

Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction

Adenocarcinoma of the esophagus stages II-III allowed

Oxaliplatin and fluorouracil (5-FU) or capecitabine

Docetaxel and/or 5-FU or paclitaxel

Disqualifiers

Prior radiation or any therapy for the treatment of esophageal cancer

Prior surgical resection of esophageal tumor

Esophageal cancer with radiographic evidence of metastases at screening

Esophageal fistula

Trial design

Treatments tested in this trial

  • Capecitabine
  • Carboplatin
  • Docetaxel
  • Fluorouracil
  • Hafnium Oxide-containing Nanoparticles NBTXR3
  • Intensity-Modulated Radiation Therapy
  • Leucovorin
  • Oxaliplatin
  • Paclitaxel

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov