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Radiation
Reduced Radiation Doses for Throat Cancer
Phase 2
Recruiting
Led By Michael Sim, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histopathologically confirmed squamous cell carcinoma
Subjects ≥ 18 years old at the time of informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 months, 6 months, 1 year, and 2 year post-treatment
Awards & highlights
Study Summary
This trial is testing if less intense treatment for throat cancer is as effective as the current standard of care.
Who is the study for?
This trial is for adults over 18 with HPV-positive throat cancer that can be removed surgically. They should have a performance status indicating they are relatively active and must not have distant spread of cancer or other cancers in the last 5 years, except certain skin and thyroid cancers. Women must not be pregnant or breastfeeding.Check my eligibility
What is being tested?
The study is testing if reducing the intensity of treatment after surgery for HPV-positive throat cancer by giving fewer radiation doses (44 instead of the standard 54) affects recovery outcomes. It aims to see if less intense treatment leads to similar or better results than current standards.See study design
What are the potential side effects?
Potential side effects from reduced radiation may include skin irritation, fatigue, dry mouth, difficulty swallowing, changes in taste, dental problems, and possibly a lower risk of long-term complications compared to standard treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed as squamous cell carcinoma.
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I am 18 years old or older.
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My cancer is in an early stage (T1 or T2).
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My cancer has spread to nearby lymph nodes but not to distant parts of my body.
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My tumor is HPV positive.
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My neck nodes can be felt and moved upon examination.
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I can take care of myself and am up and about more than half of the day.
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My tumor can likely be completely removed by surgery.
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My cancer originates in the back of my throat.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 months, 6 months, 1 year, and 2 year post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 months, 6 months, 1 year, and 2 year post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free survival
Secondary outcome measures
Distant metastasis rates
Gastrostomy tube dependence rates
Loco-regional control
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Adjuvant Radiation 54 GrayExperimental Treatment1 Intervention
If patients have 4 or fewer positive nodes with greater than 2 mm of cancer spread extending outside the lymph nodes or 5 or more positive nodes with 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 54 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.
Group II: Adjuvant Radiation 44 GrayExperimental Treatment1 Intervention
If patients have 4 or fewer positive nodes and 2 mm or less of cancer spread extending outside the lymph nodes, patients will receive 44 gray fractions (the full dose of radiation divided into smaller doses) of adjuvant radiation.
Group III: ObservationActive Control1 Intervention
If patients have negative margins and have all negative nodes or only a single positive node, patients will be placed in the observation arm and will not receive further adjuvant treatment, only postoperative follow-up visits and a surveillance visit 3 months after surgery with a CT or PET-CT.
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Who is running the clinical trial?
Indiana UniversityLead Sponsor
985 Previous Clinical Trials
1,081,064 Total Patients Enrolled
Michael Sim, MDPrincipal InvestigatorIndiana University School of Medicine, Indiana University Simon Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed as squamous cell carcinoma.I am 18 years old or older.I have a health condition that makes general anesthesia unsafe for me.I have more than one primary cancer at the same time.My cancer is in an early stage (T1 or T2).I have not had head or neck radiation or cancer in the last 3 years.I am of childbearing age and have a recent negative pregnancy test.My cancer has spread to nearby lymph nodes but not to distant parts of my body.I cannot complete all radiation treatments or attend follow-up visits.My tumor is HPV positive.My cancer has spread to distant parts of my body.My neck nodes can be felt and moved upon examination.I haven't had cancer, except for skin or thyroid cancer, in the last 3 years.I can take care of myself and am up and about more than half of the day.My tumor can likely be completely removed by surgery.My cancer originates in the back of my throat.My cancer's original source was unknown but has now been found and can be completely removed, or my tonsils have been removed and tested negative for cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Observation
- Group 2: Adjuvant Radiation 44 Gray
- Group 3: Adjuvant Radiation 54 Gray
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.
How many participants are included in the research project?
"Affirmative. Clinicaltrials.gov has records of this medical research study, that was initially announced on May 12th 2022, still recruiting participants. The team behind the project needs to find 75 people from two different sites for their experiment."
Answered by AI
What is the potential risk of receiving 54 doses of radiation?
"Considering the Phase 2 status of this study, our team at Power rated 54 doses of radiation a 2 on their safety scale due to limited data confirming efficacy but some evidence attesting to its security."
Answered by AI
Are there still open opportunities to join this experiment?
"According to clinicaltrials.gov, this trial is still looking for individuals to enrol in the study. It was first introduced on May 12th 2022 and has since been updated on October 5th of that same year."
Answered by AI
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