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Durvalumab + Radiotherapy for Oral Cancer
Study Summary
This trial is investigating whether adding the experimental drug durvalumab to radiation therapy can improve cure rates and reduce side effects for people with head and neck cancer.
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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- My cancer has spread to other parts of my body.I am currently undergoing treatment with chemotherapy, investigational drugs, or hormone therapy for cancer.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is a type of squamous cell carcinoma located in my head or neck.I had surgery to remove my cancer completely within the last 8 weeks, and my cancer has features that might make it come back.I haven't taken antibiotics in the last 7 days.I am allergic to durvalumab or its ingredients.I am not pregnant or breastfeeding and willing to use birth control during and up to 90 days after treatment.I have had lung inflammation treated with steroids or have lung disease.I have not received any treatment for my tumor before its surgical removal.My organs are functioning well according to the test results.I am a woman who can have children and have a recent negative pregnancy test.I have had cancer before, but it was either treated over 5 years ago, was a non-threatening skin cancer, or was a localized cancer that did not spread.I have an autoimmune disease that needed treatment recently or is severe.I have not had major surgery in the last 3 weeks.I do not have an active infection needing treatment like TB, hepatitis B, C, or HIV.I have a history of liver disease that is not under control.I have not taken immunosuppressive medication in the last 14 days.I cannot undergo radiation therapy due to health reasons.My weight is 40kg or less.I am willing and able to follow the study's procedures.I am a male and will use birth control during and 90 days after treatment if my partner can get pregnant.I do not have any unmanaged ongoing illnesses.
- Group 1: Open-label, single-arm
- 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
Is enrollment for this study still open?
"Unfortunately, no more patients can be enrolled in this study. It was originally published on October 7th 2019 and last updated on May 26th 2022. Fortunately, there are still 73 studies recruiting for larynx related issues and 333 trials actively enrolling participants seeking this treatment option."
Has this medication obtained the necessary regulatory endorsement?
"Based on the existing evidence, our team believes this treatment is moderately safe and thus assigned a score of 2. This is because Phase 2 trials have yielded some safety data but not yet any efficacy results."
How many individuals are engaged in this clinical research?
"The recruitment period for this trial has ended. It was posted October 7th 2019 and last updated May 26th 2022. If you are looking to join a medical study, there are currently 73 studies enrolling patients with larynx-related conditions and 333 trials recruiting participants for the same treatment as this one."
What maladies is this procedure commonly utilized to address?
"Unresectable stage III non-small cell lung cancer is frequently treated with this medication, but it can also be beneficial for individuals who have been newly diagnosed with metastatic urothelial carcinoma or need advance directives."
Are there any previous experiments that have looked at the efficacy of this treatment?
"Initially studied at City of Hope, this treatment has been the subject of 107 completed clinical trials. Presently, 333 active medical studies are taking place with a substantial amount occurring in Chapel Hill, North carolina."
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