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Radiation
Reduced-Intensity Radiation Therapy for Oropharyngeal Cancer
Phase 3
Waitlist Available
Led By Daniel Ma, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gross total surgical resection with curative intent of the primary tumor and at least unilateral neck dissection within 7 weeks of registration
Perineural invasion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is for patients with cancer of the oropharynx caused by HPV. The treatment being studied is less intense radiation given over two weeks compared to the traditional six weeks of daily radiation therapy.
Who is the study for?
This trial is for adults with HPV-related oropharyngeal cancer who've had surgery. They should be in good health, without distant metastases, and have certain risk factors like large lymph nodes or advanced disease. Pregnant/nursing individuals, those not using contraception, HIV patients, and people with severe diseases or another active cancer are excluded.Check my eligibility
What is being tested?
The study compares traditional six-week radiation therapy to a de-escalated two-week version after surgery. Patients will be randomly assigned to either the standard treatment or the new shorter regimen; chances are higher for getting the less intense option.See study design
What are the potential side effects?
Potential side effects may include skin irritation from radiation, fatigue, dry mouth/throat issues due to radiation exposure. Docetaxel and Cisplatin can cause nausea, hair loss, low blood cell counts increasing infection risk, kidney problems and hearing damage.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had surgery to remove my cancer and some neck lymph nodes within the last 7 weeks.
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My cancer has spread along my nerves.
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I have 2 or more lymph nodes that are cancer-positive.
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My kidney function is normal or only slightly reduced.
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My throat cancer is HPV positive, confirmed by a specific test.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is at a stage where it has grown into nearby tissues.
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My throat cancer is HPV positive, confirmed by a specific test.
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I had surgery to remove my cancer and some lymph nodes within the last 7 weeks.
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My cancer has spread outside the lymph node.
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I am 18 years old or older.
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I have a lymph node larger than 3 cm.
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I am 18 years old or older.
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My cancer has one of the specified high-risk features.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Grade 3+ Adverse Events Rate
Secondary outcome measures
Disease-free Survival
Distant Failure Associated With DART vs Standard Treatment
Local/Regional Control
+2 moreSide effects data
From 2018 Phase 2 trial • 60 Patients • NCT0215970367%
Dysgeusia
65%
Dermatitits radiation
55%
Dry Mouth
47%
Salivary duct inflammation
43%
Fatigue
38%
Dysphagia
33%
Lymphedema
32%
Anorexia
30%
Alopecia
30%
Mucositis oral
30%
Voice alteration
20%
Esophageal pain
18%
Mucosal infection
18%
Superficial soft tissue fibrosis
13%
Dermatitis radiation
12%
Sore throat
7%
Neck edema
7%
Aspiration
7%
Hypothyroidism
5%
Weight loss
5%
Dehydration
5%
Other Gastrointestinal disorders
5%
Hoarseness
5%
Nausea
3%
Depression
3%
Edema face
3%
Laryngeal edema
3%
Other Musculoskeletal and connective tissue disorder
3%
Oral pain
3%
Pain
3%
Trismus
2%
Vomiting
2%
Other Nervous system disorders
2%
Hypoxia
2%
Anxiety
2%
Constipation
2%
Dizziness
2%
Other Ear and labyrinth disorders
2%
Other General disorders and administration site conditions
2%
Lip pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm Phase 2
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: De-escalated Adjuvant Radiation TherapyExperimental Treatment2 Interventions
Docetaxel 15 mg/m2 days 1, 8 + Radiation Therapy (RT) 30 Gy/1.5 Gy fractions twice daily (b.i.d.) days 1-12 only (intermediate risk) or 36 Gy/1.8 Gy b.i.d. fractions (high risk)
Group II: Standard of Care TreatmentActive Control2 Interventions
RT 60 Gy/2 Gy fractions daily (qday) days 1-40. For high risk, add weekly Cisplatin 40 mg/m2 (Around days 1, 8, 15, 22, 29, 36)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adjuvant Radiation Therapy
2014
Completed Phase 2
~60
Docetaxel
1995
Completed Phase 4
~5620
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,766,855 Total Patients Enrolled
Daniel Ma, M.D.Principal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery to remove my cancer and some neck lymph nodes within the last 7 weeks.My cancer has spread along my nerves.I have swollen lymph nodes below my collarbone.I have received chemotherapy before.I am not on medications that would affect my treatment.I have 2 or more lymph nodes that are cancer-positive.I am aware the study drug may affect my DNA and could harm a pregnancy.My kidney function is normal or only slightly reduced.My throat cancer is HPV positive, confirmed by a specific test.I am currently breastfeeding.I am fully active or restricted in physically strenuous activity but can do light work.My cancer is at a stage where it has grown into nearby tissues.I am of childbearing age and do not plan to use birth control.My surgery showed cancer cells at the edge of the tissue removed.I do not have severe hearing loss or nerve damage that would prevent me from receiving cisplatin chemotherapy.My throat cancer is HPV positive, confirmed by a specific test.I had surgery to remove my cancer and some lymph nodes within the last 7 weeks.I haven't had cancer, except for non-melanoma skin cancer or cervical carcinoma-in-situ, in the last 5 years.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I have had radiation therapy on the cancer site before.My recent scans show no cancer spread to distant parts of my body.I have a history of conditions like rheumatoid arthritis, lupus, or Sjogren's disease.My cancer has spread outside the lymph node.I am 18 years old or older.I have a lymph node larger than 3 cm.I am 18 years old or older.My cancer has one of the specified high-risk features.
Research Study Groups:
This trial has the following groups:- Group 1: De-escalated Adjuvant Radiation Therapy
- Group 2: Standard of Care Treatment
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 there other ongoing studies that use Adjuvant Radiation Therapy?
"There are currently 970 Adjuvant Radiation Therapy studies underway, with 381 of them in the critical Phase 3 stage. The majority of these trials are based in Shanghai, but there are clinical trial locations all over the world."
Answered by AI
How many people can join this research project?
"Unfortunately, this clinical trial is no longer actively recruiting patients. The listing was created on October 3rd, 2016 and edited for the last time on September 8th, 2022. However, there are currently 97 trials related to oropharynx cancers and 970 studies concerning Adjuvant Radiation Therapy that are seeking participants."
Answered by AI
Are there any available positions for participants in this research project?
"According to the latest information on clinicaltrials.gov, this particular study is not looking for any more patients at this time. The trial was first posted on October 3rd 2016 and 1067 other studies are actively recruiting patients right now."
Answered by AI
What is the FDA's stance on Adjuvant Radiation Therapy?
"Adjuvant Radiation Therapy received a 3 because there is both supportive efficacy data and extensive safety data from multiple rounds of clinical trials."
Answered by AI
What types of cancer does Adjuvant Radiation Therapy usually target?
"Advance directives are most often treated with Adjuvant Radiation Therapy, but this type of treatment can also be effective for other conditions such as brca1 gene, neoplasm metastasis, and metastatic bladder cancer."
Answered by AI
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