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NCT04615013 · ClinicalTrials.gov registry record · Phase 1
NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Cancer
A Phase 1 study of Gastroesophageal Junction Adenocarcinoma and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04615013: Recruiting Phase 1 study of Gastroesophageal Junction Adenocarcinoma and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04615013 is a Phase 1 study of Gastroesophageal Junction Adenocarcinoma and Clinical Stage III Esophageal Adenocarcinoma AJCC v8 that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 24 participants, below the 404-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04615013, a Phase 1 study of Gastroesophageal Junction Adenocarcinoma and Clinical Stage III Esophageal Adenocarcinoma AJCC v8, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Will be coded and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5 criteria. Descriptive summary tables will be produced, providing the DLTs by initial planned dose level of NBTXR3, initial planned volume of NBTXR3 to be injected, the injected volume, the radiation therapy dose given and the details of the concurrent chemotherapy given.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Docetaxel
- DRUG Capecitabine
- DRUG Fluorouracil
- OTHER Hafnium Oxide-containing Nanoparticles NBTXR3
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-11-23 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 1 |
What NCT04615013 shows while recruiting
NCT04615013 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 404-participant average among 40 other Gastroesophageal Junction Adenocarcinoma trials with a reported enrollment target (94% lower).
The record links to 10 conditions, with Gastroesophageal Junction Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04615013 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04615013 about?
NCT04615013 is a clinical study titled "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 ...
What is the current status of trial NCT04615013?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-11-23. Estimated completion is 2027-10-31.
What conditions does trial NCT04615013 study?
This clinical trial studies the following conditions: Gastroesophageal Junction Adenocarcinoma, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage II Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8, Clinical Stage IIB Esophageal Adenocarcinoma AJCC v8.
What interventions are being tested in trial NCT04615013?
The interventions under investigation include: Carboplatin (DRUG), Docetaxel (DRUG), Capecitabine (DRUG), Fluorouracil (DRUG), Hafnium Oxide-containing Nanoparticles NBTXR3 (OTHER).
Who is sponsoring clinical trial NCT04615013?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04615013 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04615013's enrollment target sits among peer trials
24 36th of 40 higher than 5 of 40 other Gastroesophageal Junction Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastroesophageal Junction Adenocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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