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Transoral Surgery + Reduced-Dose Radiation/Chemotherapy for Oropharyngeal Cancer
Phase 2
Waitlist Available
Led By Matin Imanguli, MD, DDS
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have tumors deemed surgically resectable with acceptable morbidity
Clinical stage T1-2, N0-N3, M0 by American Joint Committee on Cancer (AJCC) 8 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 24 weeks and 1 year post completion of therapy
Awards & highlights
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.
Who is the study for?
This trial is for adults with HPV-related throat cancer that can be surgically removed. Participants must have certain blood and organ function levels, not have had previous treatments for head and neck cancer, and women of childbearing age must test negative for pregnancy and use birth control. People with metastatic disease beyond the neck or serious health issues are excluded.Check my eligibility
What is being tested?
The study tests if lower doses of radiation therapy and chemotherapy after surgery can maintain survival rates while improving quality of life in patients with HPV-caused throat cancer. It's a phase II trial where everyone gets the same treatment without being randomly assigned to different groups.See study design
What are the potential side effects?
Potential side effects include those related to surgery, radiation therapy (like skin irritation, fatigue), chemotherapy (nausea, low blood counts), as well as specific reactions from each intervention used in this particular combination.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor can be removed with surgery safely.
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My cancer is in an early to mid-stage and has not spread to distant parts of my body.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I can take care of myself but may not be able to do heavy physical work.
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My cancer is a type of throat cancer called squamous cell carcinoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 24 weeks and 1 year post completion of therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 24 weeks and 1 year post completion of therapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MD Anderson Dysphagia Index (MDADI)
Secondary outcome measures
Correlation of circulating tumor deoxyribonucleic acid (ctDNA) levels with known adverse pathological features
Disease free survival.
European Quality of Life Five Dimension Five Level Scale Questionnaire scores
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: GROUP III - High Risk Recurrence (transoral surgery, EBRT 60Gy, cisplatin 30 mg/m2)Experimental Treatment9 Interventions
Patients whose tumor has a "positive margin", which means the tumor could not be removed with healthy tissue around it or tumor grows significantly outside the lymph node will undergo EBRT RT 60 Gy for 6 weeks and receive cisplatin intravenously (IV) weekly 30mg/m2 for 6 weeks in the absence of disease progression or unacceptable toxicity.
Group II: GROUP II - Medium Risk Recurrence (transoral surgery, EBRT 50Gy)Experimental Treatment8 Interventions
Patients whose tumor was removed completely but has certain features that make it more likely to come back such as growth around the nerves or into the vessels, or has more than one lymph nodes involved, will undergo external body radiation therapy (EBRT) RT 50Gy for 5 weeks in the absence of disease progression or unacceptable toxicity.
Group III: GROUP I - Low Risk Recurrence (transoral surgery, clinical observation))Active Control7 Interventions
After standard of care transoral surgery, patients whose small tumor was removed completely and have only one lymph node involved will undergo clinical observation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3150
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
430 Previous Clinical Trials
64,643 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,714 Total Patients Enrolled
Matin Imanguli, MD, DDSPrincipal InvestigatorRutgers Cancer Institute of New Jersey
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- 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)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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