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Chemotherapy

NBTXR3 + Chemoradiation for Esophageal Cancer

Phase 1
Recruiting
Led By Steven H Lin
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adenocarcinoma of the esophagus stages II-III allowed
Amenable to undergo the endoscopic ultrasound (EUS) guided injection of NBTXR3 as determined by the investigator or treating physician
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from nbtxr3 injection to local recurrence, local progression, distant progression, confirmed radiographically (recist version 1.1), or death from any cause, whichever occurs first, assessed up to 1 year
Awards & highlights

Study Summary

This trial will test the safety of NBTXR3 activated by radiation therapy given with concurrent chemotherapy in patients with esophageal adenocarcinoma.

Who is the study for?
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.Check my eligibility
What is being tested?
The study is testing NBTXR3 nanoparticles activated by radiation therapy alongside standard chemotherapy drugs (like oxaliplatin and fluorouracil) to see if this combination better controls esophageal cancer compared to current treatments.See study design
What are the potential side effects?
Potential side effects include typical chemotherapy-related issues like nausea, fatigue, low blood cell counts leading to increased infection risk; radiation may cause skin irritation or difficulty swallowing. The new drug's side effects are being studied but could involve similar reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My esophageal cancer is at stage II or III.
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My doctor agrees I can have an injection guided by ultrasound.
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer is a type of adenocarcinoma located in the esophagus or where the stomach meets the esophagus.
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I can undergo chemoradiation and can take specific chemotherapy drugs.
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I have 1 to 4 measurable tumors in my esophagus.
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My cancer is confirmed in the esophagus or where it meets the stomach.
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I am able to get out of my bed or chair and move around.
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My cancer has spread to lymph nodes that are larger than 15 mm.
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My cancer has spread to the lymph nodes near my esophagus.
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I have 1 to 4 measurable tumors in my esophagus.
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My doctor can inject my tumor even if a scope can't pass through it.
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I can undergo chemoradiation and can take specific chemotherapy drugs.
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My cancer has spread to lymph nodes that are larger than 15 mm.
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My condition is stage II-III esophageal adenocarcinoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from nbtxr3 injection to local recurrence, local progression, distant progression, confirmed radiographically (recist version 1.1), or death from any cause, whichever occurs first, assessed up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from nbtxr3 injection to local recurrence, local progression, distant progression, confirmed radiographically (recist version 1.1), or death from any cause, whichever occurs first, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose limiting toxicities (DLTs)
Maximum tolerated dose and recommended phase 2 dose (RP2D)
Secondary outcome measures
Distant progression-free survival
Feasibility of NBTXR3 injection in the esophageal tumor and involved regional lymph nodes
Incidence of NBTXR3/radiation therapy related late onset toxicities
+5 more
Other outcome measures
Changes in radiomic measurements
Concordance of cell free deoxyribonucleic acid (DNA)
Cytokine profiling
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (NBTXR3, IMRT, chemotherapy)Experimental Treatment9 Interventions
Patients receive NBTXR3 IT or IN on day 1. Beginning day 15, patients undergo IMRT 5 days per week for 6 weeks for a total of 28 fractions, in the absence of disease progression or unacceptable toxicity. 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Paclitaxel
FDA approved
Carboplatin
FDA approved
Docetaxel
FDA approved
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Oxaliplatin
FDA approved
Leucovorin
FDA approved
Capecitabine
FDA approved

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,317 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,341 Total Patients Enrolled
Steven H LinPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
64 Total Patients Enrolled

Media Library

Capecitabine (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT04615013 — Phase 1
Esophageal Cancer Research Study Groups: Treatment (NBTXR3, IMRT, chemotherapy)
Esophageal Cancer Clinical Trial 2023: Capecitabine Highlights & Side Effects. Trial Name: NCT04615013 — Phase 1
Capecitabine (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04615013 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what malignancies is Intensity-Modulated Radiation Therapy typically applied?

"Intensity-Modulated Radiation Therapy (IMRT) is the go-to treatment for actinic keratosis, as well as macrocytic anemia, neoplasm metastasis and lymphoma non-hodgkin."

Answered by AI

What is the end goal of this clinical experiment?

"The primary metric to be observed during the duration of this trial (ending at day 85) is Maximum tolerated dose and recommended phase 2 dose (RP2D). Secondary outcomes that will also be appraised include Distant progression-free survival, Major pathological response rate, and Incidence of NBTXR3/radiation therapy related late onset toxicities. These metrics will be estimated using a combination of Kaplan and Meier's method as well as Modified Ryan Scheme for Tumor Regression Score. Median times along with 95% confidence intervals shall also be gauged per dosage level."

Answered by AI

What precedent has been established for utilizing Intensity-Modulated Radiation Therapy in clinical trials?

"Presently, there are 1936 clinical trials active for Intensity-Modulated Radiation Therapy with 604 of these being in the most advanced phase. A majority of these studies are hosted by centres located in Guangzhou, Guangdong; nevertheless, this modality is also evaluated at 98899 other venues around the world."

Answered by AI

What risks do individuals face when undergoing Intensity-Modulated Radiation Therapy?

"Limited clinical data exists to support the efficacy and safety of Intensity-Modulated Radiation Therapy leading it to be assigned a score of 1."

Answered by AI

Are there any vacancies for prospective participants in this clinical trial?

"According to clinicaltrials.gov, recruitment for this trial is still open; the initial posting was on November 23rd 2020 and most recent update was made August 17th 2022."

Answered by AI

What amount of patients are being selected to participate in this research?

"Indeed, the information accessible on clinicaltrials.gov demonstrates that this experiment is still recruiting participants. This study was initially published in November 23rd 2020 and has since been edited as recently as August 17th 2022. A total of 24 individuals are required to join from one medical centre."

Answered by AI
~8 spots leftby Oct 2025