NBTXR3 + Chemoradiation for Esophageal Cancer
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves specific chemotherapy drugs, it's best to discuss your current medications with the trial team to ensure there are no interactions.
What data supports the effectiveness of the drug NBTXR3 + Chemoradiation for Esophageal Cancer?
Research shows that combinations of drugs like docetaxel and 5-fluorouracil (5-FU) are effective in treating advanced esophageal cancer, with low toxicity. Additionally, paclitaxel-based regimens, often used with carboplatin or cisplatin, are widely used in chemoradiation therapy for esophageal cancer, suggesting potential effectiveness of similar combinations.12345
Is the combination of NBTXR3 and chemoradiation safe for treating esophageal cancer?
The combination of drugs like docetaxel, 5-fluorouracil, and carboplatin, which are part of chemoradiation treatments for esophageal cancer, can have side effects such as febrile neutropenia (fever with low white blood cell count) and other blood-related issues. However, studies suggest that these treatments are generally tolerable, meaning they are safe enough for use under medical supervision.35678
What makes the NBTXR3 + Chemoradiation treatment for esophageal cancer unique?
Research Team
Steven H. Lin, MD
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with esophageal adenocarcinoma stages II-III who haven't had prior treatments for their cancer. They must have a certain level of blood cells, organ function, and be able to undergo specific diagnostic tests. Pregnant or breastfeeding women can't participate, nor those with other active cancers or serious medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive NBTXR3 intratumorally or intranodally on day 1, followed by intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy starting on day 15 for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Capecitabine
- Carboplatin
- Docetaxel
- Fluorouracil
- Leucovorin
- NBTXR3
- Paclitaxel
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator