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Chemotherapy + Immunotherapy Before Surgery for Head and Neck Cancer
Study Summary
This trial is testing a chemotherapy regimen to see if it can effectively treat squamous cell carcinoma of the head and neck while also reducing side effects.
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 do not have active liver or bile duct disease, except for Gilbert's syndrome, gallstones without symptoms, or stable chronic liver disease.My cancer has spread to other parts of my body.I agree to use birth control during the study.I have been diagnosed with tuberculosis in the past.Your heart's electrical activity (QT interval) is longer than normal when corrected for your heart rate.You have had a bad reaction to durvalumab or any of its ingredients in the past.I had major surgery less than 28 days ago and haven't fully recovered.I haven't taken immunosuppressive drugs in the last 14 days.I have HIV, HCV, or active HBV.I have not received a live vaccine in the last 30 days.Women who can have babies must have a negative pregnancy test within 72 hours before starting the treatment.I have no other cancers except for certain low-risk types or those I've been free of for 5+ years.I am not currently on any cancer treatments like chemotherapy or hormone therapy.I am a male and will use birth control during and for 6 months after the study.I have been treated with a PD-1 or PD-L1 inhibitor before.I cannot have radiotherapy due to a genetic condition.I am fully active or can carry out light work.My liver and kidney functions are within normal ranges.I have a type of throat cancer that has not spread and can be removed by surgery.I am 18 years old or older.I have had an organ transplant.I am not pregnant, breastfeeding, and if of childbearing potential, I am using effective birth control.I have had or currently have pneumonitis.You have a history of a weak immune system since birth.I am willing and able to follow the study's treatment and visit schedule.My throat cancer is caused by a low-risk HPV infection.My blood tests show normal white blood cells, hemoglobin, and platelets.I do not have any serious infections or health conditions that could risk my safety in the study.You have a disease that can be measured using a specific set of guidelines.I have had an autoimmune or inflammatory disorder in the last 2 years.
- Group 1: Low Risk
- Group 2: Medium Risk
- Group 3: High Risk
- 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
What other types of surgeries have been explored in clinical trials?
"Surgical resection was first explored in 1997 at the City of Hope Comprehensive Cancer Centre. As of now, 2394 trials have been concluded while 1769 are currently underway; many of these studies taking place in Nashville, Tennessee."
Are any openings still available for potential participants in this clinical experiment?
"This trial is currently not accepting patient applications. It was initial launched in December of 2017 and last updated at the end May 2021. Alternatively, there are 2,923 clinical trials focusing on laryngeal cancer that are open for recruitment and 1,769 active studies pertaining to Surgical resection recruiting participants."
What is the scope of involvement for this research protocol?
"Unfortunately, this trial is not presently seeking new patients. Initially posted on December 19th 2017 and last updated on May 26th 2022, interested participants should consider the 2923 clinical trials actively recruiting laryngeal cancer sufferers or 1769 studies for surgical resection instead."
To what types of ailments is Surgical resection typically applied?
"Surgical resection is commonly used to manage advanced non small cell lung cancer (nsclc) as well as recurrent, advance directives and other forms of soft tissue sarcoma (sts)."
Has the FDA declared its approval of Surgical resection?
"Our team at Power deemed the safety of surgical resection to be a 2 because no efficacy data exists yet. However, there is preliminary evidence suggesting it is safe for use in this medical trial."
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