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Alkylating agents
Chemotherapy + Reduced-Dose Radiation for Throat Cancer (ENID Trial)
Phase 2
Recruiting
Led By Gregory Biedermann, MD
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); cytologic diagnosis from a cervical lymph node is sufficient in the presence of clinical evidence of a primary tumor in the oropharynx. Clinical evidence should be documented, may consist of palpation, imaging, or endoscopic evaluation, and should be sufficient to estimate the size of the primary (for T stage).
Serum creatinine < 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two years post treatment
Awards & highlights
ENID Trial Summary
This trial will explore giving standard dose chemotherapy and radiation therapy to sites of disease including all lymph nodes involved with HPV-positive oropharyngeal cancer, but administering lower doses of radiation therapy to the lymph nodes that are not known to be involved with cancer.
Who is the study for?
This trial is for low-risk patients with HPV-positive oropharyngeal cancer who have not had prior invasive malignancies (except certain skin cancers) in the last 5 years, no previous radiotherapy overlapping the study area, and no chemotherapy for their current cancer. They must be generally healthy, non-heavy smokers or willing to quit, and women of childbearing age should use contraception.Check my eligibility
What is being tested?
The trial tests if giving standard dose chemotherapy alongside radiation therapy directly to areas affected by HPV-positive oropharyngeal cancer—and lower doses to unaffected lymph nodes—can control the disease while reducing long-term side effects and improving life quality after treatment.See study design
What are the potential side effects?
Potential side effects include those commonly associated with radiation therapy such as fatigue, skin reactions at the treated site, difficulty swallowing, dry mouth; and from Cisplatin injection like nausea, kidney issues, hearing problems and nerve damage.
ENID Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of throat cancer.
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My kidney function is normal, with creatinine levels below 1.5 mg/dl or clearance above 50 ml/min.
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I have had a CT scan of my neck with contrast and a chest CT scan.
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My cancer tissue tested positive for p16.
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My cancer is in stages T1-T3, N0-N2, and has not spread far.
ENID Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 and 2 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 and 2 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of PEG tube placement
Secondary outcome measures
Dysphagia index
Hypothyroidism incidence
Patient Reported Outcomes
+3 moreENID Trial Design
1Treatment groups
Experimental Treatment
Group I: Open label single-arm studyExperimental Treatment1 Intervention
All patients will receive concurrent cisplatin and radiation therapy with radiation dose de-escalation to clinically and radiologically uninvolved lymph nodes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin injection
2014
Completed Phase 3
~100
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
362 Previous Clinical Trials
628,086 Total Patients Enrolled
Gregory Biedermann, MDPrincipal Investigator - University of Missouri - Ellis Fischel Cancer Center
Boone Hospital Center, Capital Region Medical Center, Lake Regional Health System
St Louis University School Of Medicine (Medical School)
Boston Medical Center (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is in the early stages and located in my tonsil.I have been diagnosed with a specific type of throat cancer.I've had a throat exam using a special scope within the last 60 days.I have had an MRI of the neck with contrast and a chest CT scan.My kidney function is normal as per recent tests.My cancer originates from the mouth, nasopharynx, hypopharynx, or larynx.I have been cancer-free for at least 5 years, except for non-melanoma skin cancer.I have smoked less than 10 pack years or have quit before starting radiation therapy.I have been mostly active and able to carry out all pre-disease activities up to 30 days before signing up.My kidney function is normal, with creatinine levels below 1.5 mg/dl or clearance above 50 ml/min.I have had a CT scan with contrast of my neck and a PET/CT scan of my neck and chest.I've had surgery to remove all visible cancer from the primary site and lymph nodes.I do not have an active bacterial or fungal infection needing IV antibiotics.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.I do not have liver problems causing jaundice or blood clotting issues.My CT or PET/CT scan was used for both cancer staging and radiation planning.I have not had radiation in the same area where my current cancer is.I have a neck carcinoma with an unknown primary origin.I haven't been hospitalized for COPD or other lung issues in the last 30 days.I had a major heart attack in the last 6 months.I am willing to use birth control during and up to 60 days after the trial.My cancer can be seen or measured on scans, and I may have had minor surgery to remove some of it.My cancer has spread to lymph nodes that are larger than 6 cm.I have had a CT scan of my neck with contrast and a chest CT scan.My hemoglobin level is at least 8.0 g/dl.I have more than one primary cancer or tumors in both sides of a body part.I am mentally and physically able to follow the study's requirements.My cancer tissue tested positive for p16.My cancer is in stages T1-T3, N0-N2, and has not spread far.I have had an MRI with contrast of my neck and a PET/CT scan of my neck and chest.My cancer has spread to the lymph nodes near my collarbone.My scans show cancer has spread below my collarbone.I have had chemotherapy for this cancer before.My liver is working well, as confirmed by recent tests.You have a serious health condition that is currently active and could affect your ability to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Open label single-arm study
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.
Has this treatment been officially validated by the FDA?
"As this is a Phase 2 clinical trial, an assessment of the safety profile gave rise to a score of 2 due to limited evidence supporting efficacy."
Answered by AI
What are the typical indications for this particular therapy?
"Advanced ovarian cancer is frequently treated with this therapeutic intervention, however it can also be employed to treat other maladies such as advanced testicular cancer that have been nonresponsive to conventional treatments and advance directives."
Answered by AI
How many participants are currently enrolled in this research study?
"Affirmative. Clinicaltrials.gov has revealed that the trial, which first appeared on 28th September 2020, is presently recruiting participants. Altogether, 28 people need to be enlisted at a single site."
Answered by AI
Is this medical experiment currently accepting participants?
"The trial, which was opened on September 28th 2020 and last updated October 31st 2022, is currently seeking participants. Clinicaltrials.gov offers this information for potential candidates to review."
Answered by AI
Are there any precedents of this treatment being tested in a medical research setting?
"At present, 689 medical trials are actively researching this treatment with 274 of these studies in Phase 3. Shanghai is one hub for research on the subject but there are over four thousand other sites worldwide conducting relevant experiments."
Answered by AI
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