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Radiotherapy + Durvalumab for Squamous Cell Carcinoma
Study Summary
This trial is testing a new cancer treatment and studying its safety. Patients must have a certain type of head and neck cancer that has not spread and must be able to have surgery.
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 older than 18 years.I have had cancer before, but it meets the trial's exceptions.I have had cancer spread to the lining of my brain and spinal cord.I am fully active and can carry on all pre-disease activities without restriction.You are expected to live for at least 24 weeks.You are allergic or hypersensitive to any of the study drugs or their ingredients.I am considered a good candidate for surgery by my ENT surgeon and I am willing to undergo surgery.Your hemoglobin level must be at least 9.0 grams per deciliter (g/dL).My cancer is in the oral cavity, larynx, hypopharynx, or oropharynx and is stage II-IVB.My cancer is in the oral cavity, larynx, hypopharynx, or oropharynx and is stage II-IVB.I am considered a good candidate for surgery by an ENT surgeon and I am willing to undergo surgery.I am older than 18 years.I have not taken any drugs targeting immune checkpoints.I received my last cancer treatment more than 30 days ago, or more than 6 weeks ago if it was nitrosourea or mitomycin C.I am not on any cancer treatments not recommended by NCCN for head and neck cancer.I do not have active infections like TB, hepatitis B, C, or HIV.I am not pregnant or breastfeeding and willing to use effective birth control.My body weight is over 30kg.I am post-menopausal or not currently pregnant.I am willing and able to follow the study's treatment plan and attend all visits.You must give permission in writing and sign a form that says it's okay for doctors to perform tests and treatments related to the study.You have participated in another study testing a new medication within the past 3 months.I do not have any unmanaged ongoing illnesses.You are expected to live for at least 24 more weeks.You have a normal level of a certain type of white blood cell called neutrophils.My cancer can be measured and is larger than 10 mm.My body weight is over 30kg.My cancer is p16-positive or in the throat, sinus, neck with unknown origin, or has spread from the start.My organs and bone marrow are functioning well.I have or had an autoimmune or inflammatory disorder.I have not received a live vaccine in the last 30 days.I am fully active and can carry on all pre-disease activities without restriction.I haven't taken strong immune-weakening medicines in the last 14 days, except for common allergy or asthma treatments.I have or had lung inflammation that needed steroids.I have had an organ or bone marrow transplant from a donor.
Frequently Asked Questions
How many people are enrolled in this experiment?
"Unfortunately, this clinical trial has temporarily ceased recruiting. Originally posted on November 1st 2018 and last updated May 12th 2022, it is presently not accepting candidates. However, there are 2675 cancer trials involving squamous cells actively seeking participants along with 333 studies for Durvalumab that need volunteers."
What earlier experiments have been done with Durvalumab in a clinical setting?
"Currently, 333 clinical trials are underway studying the effects of durvalumab with 52 being in Phase 3. Though primarily based in Cordoba, Texas, this research is taking place at 12952 different sites worldwide."
Are there still opportunities for participation in this trial?
"This trial, which was initially posted on November 1st 2018 and last updated in May 12th 2022, is no longer recruiting patients. Nevertheless, other clinical trials are actively seeking participants; according to the records provided by clinicaltrials.gov there are 3008 such projects available at this time."
Are there any adverse effects associated with the use of Durvalumab?
"The safety profile of Durvalumab was assessed to be a 1 as this is an early Phase 1 trial, which has limited clinical data on its effectiveness and potential risks."
What ailments has Durvalumab been prescribed to treat?
"Durvalumab is routinely utilized to manage advanced, inoperable stage iii non-small cell lung cancer. Additionally, this medication can be prescribed for the treatment of metastatic urothelial carcinoma and other serious medical conditions."
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