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Stereotactic Body Radiation Therapy + Durvalumab ± Tremelimumab for Oropharyngeal Squamous Cell Cancer
Study Summary
This trial is testing a combination of two cancer treatments - radiation therapy and immunotherapy - to see if they're effective in treating HPV-positive oropharyngeal squamous cell cancer.
- Human Papillomavirus
- Squamous Cell Carcinoma
- Oropharyngeal Carcinoma
- Oropharyngeal Cancer
- Neoplastic Cells Present
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 2 trial • 29 Patients • NCT02045446Trial Design
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- You have had an organ transplant from someone else (not your own body).You have a current illness that is not being properly managed.You have had head and neck cancer that has come back.You have been diagnosed with a type of throat cancer called squamous cell carcinoma that is caused by the human papillomavirus (HPV). This will be confirmed by a test called immunohistochemistry that looks for a protein called p16.You have cancer that can be surgically removed and the doctor thinks you are a good candidate for the specific type of surgery called TORS.You are able to perform daily activities with minor assistance.Your hemoglobin level is at least 9.0 grams per deciliter.You can participate in the study if you have smoked for less than 20 years.You have had another type of cancer before, except for certain cases.You have cancer in both sides of your body at the same time.You cannot have received a live vaccine within 30 days before starting the study or within 30 days after receiving durvalumab or tremelimumab.The cancer is only in a few lymph nodes in the neck and they are located next to each other.You weigh at least 50 kilograms.You are able to have surgery after receiving neoadjuvant therapy and you are willing to have the surgery.You need to have had specific imaging tests done recently to participate in this study.You or your legal representative have given written permission before any testing or procedures related to the study can be done.You are currently receiving treatment for cancer.You have a current or past history of autoimmune or inflammatory disorders.It is okay to participate if you have smoked for less than 20 years.You have a medical condition that could make it difficult to evaluate the study treatment or understand the study's results.You have seizures that are not under control.You cannot participate if you are already part of another clinical trial.If you are a woman who is pregnant or breastfeeding, or if you have the ability to become pregnant and do not plan to use two highly effective forms of birth control, you cannot participate in the study.
- Group 1: Cohort II (SBRT, durvalumab,tremelimumab,TORS,neck dissection)
- Group 2: Cohort I (SBRT, durvalumab, TORS, neck dissection)
- 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 are the researchers' goals for this experiment?
"The primary outcome of this study, which will be measured over a Up to 2 years time frame, is the Incidence of adverse events (Phase I safety lead-in) assessed Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4.03 criteria. Secondary outcomes include Primary tumor control determined by RECIST v. 1.1, Rate of contralateral neck failure , and Incidence of adverse events assessed by CTCAE v4 ."
Are investigators still looking for more test subjects?
"Unfortunately, this particular study isn't looking for new volunteers at the moment. However, there are many other ongoing trials that might be a match for your needs. For example, there are 2800 studies actively looking for patients with pathologic stage ii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8 and 345 trials for Stereotactic Body Radiation Therapy actively searching for patients."
Does Stereotactic Body Radiation Therapy have a history of success in clinical trials?
"As of now, there are 345 different ongoing clinical trials investigating Stereotactic Body Radiation Therapy. Out of those active studies, 51 have reached Phase 3. Although the majority of research for this treatment takes place in Cordoba, Texas, there are 13051 total locations running these sorts of tests and experiments."
How many human participants are being included in this research project?
"This study is not recruiting at this time. It was posted on October 4th, 2018 and last edited November 14th, 2022. However, there are 345 other trials for Stereotactic Body Radiation Therapy actively enrolling participants and 2800 trials in general that may be of interest."
What sorts of cancer does SBRT help to fight?
"Unresectable stage III non-small cell lung cancer is most commonly treated with Stereotactic Body Radiation Therapy. This treatment method can also be useful for treating other conditions like previously untreated, metastatic ureter urothelial carcinoma and advance directives."
What are the unique aspects of this particular clinical trial?
"Since 2007, there has been an uptick in research surrounding Stereotactic Body Radiation Therapy. In 2007, the first trial was conducted with 37 patients and was sponsored by AstraZeneca. After this initial study, Phase 2 drug approval was given to move forward with more clinical trials. As of now, 345 active trials are taking place across 1325 cities and 58 countries."
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