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Adavosertib + Radiation for Esophageal Cancer
Study Summary
This trial tests a combo of adavosertib and radiation to treat esophageal/gastroesophageal cancer with no available treatment. It may stop growth of tumor cells & radiation kills them to shrink tumors.
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.Side effects data
From 2023 Phase 1 & 2 trial • 76 Patients • NCT02095132Trial Design
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Who is running the clinical trial?
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- I don't have long QT syndrome, a history of Torsades de pointes, recent heart attack, or ventricular arrhythmias.I've had radiation therapy in my chest or belly area that might overlap with new treatment areas.My recent ECG shows no significant heart issues.I have another cancer type, but it won't affect this trial's treatment.My hepatitis B is under control with treatment.I agree to use birth control during and after the study, and I am not pregnant.I am not pregnant or breastfeeding.My doctor does not believe I need immediate treatment for my brain metastases.I have recovered from side effects of previous cancer treatments, except for hair loss.My brain scans show no worsening after treatment for brain metastases.My kidney function is within the safe range for the trial.I can swallow whole capsules.I am fully active or able to carry out light work.I am 18 years old or older.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I am not taking any strong CYP3A4 inhibitors or inducers.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.My esophageal cancer is confirmed and cannot be removed by surgery or treated with chemoradiation.I do not have any unmanaged ongoing illnesses.I can understand and am willing to sign the consent form. If I'm unable, someone can consent for me.I haven't had chemotherapy or radiotherapy in the last 3 weeks.My current medications won't interfere with the trial drug, as confirmed by the principal investigator.You are expected to live for at least 3 more months.You are currently taking part in another experimental treatment.
- Group 1: Treatment (radiation therapy, adavosertib)
- 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
Has Adavosertib been granted authorization by the Food and Drug Administration?
"Due to its Phase 1 status, Adavosertib has been assigned a score of 1 on the safety scale. This is because there is only preliminary evidence that this drug may be effective and safe for use in humans."
What is the scope of patients enrolled in this experiment?
"Unfortunately, recruitment for this study has concluded. It was first listed on October 7th 2020 and had its last update March 16th 2023. For those looking to participate in other trials, there are 5668 studies currently recruiting patients with esophageal cancer and 17 involving Adavosertib that require participants."
Are there any published accounts of research employing Adavosertib?
"In 2013, the University of Alabama at Birmingham Cancer Center pioneered research into Adavosertib. Since then, 135 trials have been conducted and 17 are presently recruiting from various locations; notably Salt Lake City in Utah has a large quantity of active studies."
Are there any vacancies in this trial at the moment?
"At this juncture, this clinical trial is not open for participant enrollment. It was originally posted on October 7th 2020 and has had its information updated as recently as March 16th 2023. Alternatively, 5668 studies are currently looking to recruit esophageal cancer patients while 17 trials need participants with Adavosertib treatments."
What is the ultimate outcome of this clinical examination?
"This clinical trial will evaluate the incidence of adverse events over a predetermined period. Secondary objectives encompass symptom relief rate, overall survival, and Ogilvie dysphagia scores - which measure patient dysphagia before and after treatment. Results for these outcomes will be analysed with 95% binomial confidence intervals, Kaplan-Meier methods (with median survival times) or paired t-tests/Wilcoxon signed-rank tests respectively."
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