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

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 b

Trial Details

NCT ID
NCT04615013
Phase
PHASE1
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Cervical Cancer
Interventions
  • Capecitabine
  • Carboplatin
  • Docetaxel
  • Fluorouracil
  • Hafnium Oxide-containing Nanoparticles NBTXR3
  • Intensity-Modulated Radiation Therapy
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Biopsy proven adenocarcinoma of the cervical or thoracic esophagus or gastroesophageal junction
  • Adenocarcinoma of the esophagus stages II-III allowed
  • Medically able to receive chemoradiation. Following chemotherapy regimens are allowed:
  • Oxaliplatin and fluorouracil (5-FU) or capecitabine

For full eligibility, visit ClinicalTrials.gov.

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