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NBTXR3 + Chemoradiation for Esophageal Cancer
Study Summary
This trial will test the safety of NBTXR3 activated by radiation therapy given with concurrent chemotherapy in patients with esophageal adenocarcinoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I am considered suitable for a special ultrasound-guided injection as decided by my doctor.I do not have severe, active ulcers in my esophagus or stomach.My esophageal cancer has spread, as shown in scans.My esophageal cancer is at stage II or III.I am allergic to iodine or gadolinium IV contrasts.My doctor agrees I can have an injection guided by ultrasound.I can take care of myself and am up and about more than half of my waking hours.My cancer is a type of adenocarcinoma located in the esophagus or where the stomach meets the esophagus.I do not have an active, uncontrolled HIV or hepatitis B/C infection.I have 1 to 4 measurable tumors in my esophagus.My cancer is confirmed in the esophagus or where it meets the stomach.I am not pregnant or breastfeeding.I am able to get out of my bed or chair and move around.I can undergo chemoradiation and can take specific chemotherapy drugs.I have had surgery to remove an esophageal tumor.I do not have any severe illnesses that could interfere with the treatment.My cancer has spread to lymph nodes that are larger than 15 mm.My tumor is located above the main airway and hasn't spread to it.I have received treatment for esophageal cancer before.My cancer has spread to the lymph nodes near my esophagus.I have 1 to 4 measurable tumors in my esophagus.My doctor can inject my tumor even if a scope can't pass through it.I am using effective birth control methods during the study.My cancer is large or near my windpipe, posing a risk of creating a hole between my windpipe and esophagus.I can undergo chemoradiation and can take specific chemotherapy drugs.I have a history of specific esophageal or tracheoesophageal conditions.I have esophageal cancer and no other active cancers, except possibly low-risk skin or prostate cancer that has been treated and stable for 3+ months.My cancer has spread to the lymph nodes near my esophagus.My cancer has spread to lymph nodes that are larger than 15 mm.My doctor can inject my tumor even if a scope can't pass through it.My condition is stage II-III esophageal adenocarcinoma.
- Group 1: Treatment (NBTXR3, IMRT, chemotherapy)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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