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Transoral Surgery + Reduced-Dose Radiation/Chemotherapy for Oropharyngeal Cancer
Study Summary
This trial is testing a new, reduced-dose radiation therapy and chemotherapy approach for treating patients with HPV caused throat cancer. This new approach may improve quality of life without compromising survival.
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 have not had treatment for my head and neck cancer, except for a biopsy.I had another type of cancer but have been cancer-free for 3 years, or I have in situ carcinoma or non-melanoma skin cancer.I am not pregnant and agree to use birth control during and 6 months after the study.My tumor can be removed with surgery safely.My cancer is in an early to mid-stage and has not spread to distant parts of my body.My hemoglobin level is above 8 g/dl, transfusions are okay.My kidney function, measured by creatinine levels or clearance, is within the required range.My cancer has not spread beyond my neck.I can take care of myself but may not be able to do heavy physical work.I have HIV with a CD4 count over 499 and a viral load under 50, and I may be on HAART.My cancer is a type of throat cancer called squamous cell carcinoma.My tumor cannot be surgically removed without high risk due to its size or location.I am under 18 years old.My electrolyte levels are severely abnormal despite attempts to correct them.
- Group 1: GROUP III - High Risk Recurrence (transoral surgery, EBRT 60Gy, cisplatin 30 mg/m2)
- Group 2: GROUP I - Low Risk Recurrence (transoral surgery, clinical observation))
- Group 3: GROUP II - Medium Risk Recurrence (transoral surgery, EBRT 50Gy)
- 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
Are new participants being welcomed into this medical experiment at the moment?
"Affirmative. The information available on clinicaltrials.gov ascertains that this investigation, which was initially posted on July 19th 2021, is actively recruiting participants. In total 40 patients need to be recruited from 3 medical sites."
What maladies can be treated through the evaluation of Circulating tumor deoxyribonucleic acid (ctDNA) levels?
"To manage advanced ovarian cancer, clinicians often use circulating tumor deoxyribonucleic acid (ctDNA) levels assessments. Additionally, this method of detection can be successful for other treatment-resistant diseases such as advance testicular cancer and advance directives."
Are there any related investigations which have evaluated Circulating tumor deoxyribonucleic acid (ctDNA) concentrations?
"Currently, there are 688 active clinical studies that examine Circulating tumor deoxyribonucleic acid (ctDNA) levels. Of them, 274 trials have already entered Phase 3 status and 43211 medical sites around the world are offering these investigations; particularly in Shanghai."
Does the FDA recognize assessment of Circulating tumor deoxyribonucleic acid (ctDNA) levels as viable?
"Considering there is only data attesting to its safety, but no evidence of efficacy yet, the risk profile associated with Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment was evaluated as a 2."
What is the total enrollment figure for this experiment?
"Affirmative, the information posted on clinicaltrials.gov confirms that this medical experiment is currently recruiting participants. First published on July 19th 2021, it has since been updated February 16th 2022 and requires 40 test subjects from 3 different facilities."
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