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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
Must not have
Adenopathy below the clavicles
Prior systemic chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is for patients with HPV-related oropharynx cancer. It tests a new radiation therapy that uses a lower dose over a shorter period. The goal is to reduce side effects while still effectively treating the cancer. The treatment of oropharyngeal cancer has shifted from surgery to radiotherapy, and the discovery of HPV's role has led to efforts to minimize treatment toxicity.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have swollen lymph nodes below my collarbone.
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I have received chemotherapy before.
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I am aware the study drug may affect my DNA and could harm a pregnancy.
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I am of childbearing age and do not plan to use birth control.
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My surgery showed cancer cells at the edge of the tissue removed.
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I am currently breastfeeding.
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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
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I have had radiation therapy on the cancer site before.
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I have a history of conditions like rheumatoid arthritis, lupus, or Sjogren's disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Grade 3+ Adverse Events Rate
Secondary study objectives
Disease-free Survival
Local/Regional Control
Overall Survival
+1 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%
Mucositis oral
30%
Alopecia
30%
Voice alteration
20%
Esophageal pain
18%
Mucosal infection
18%
Superficial soft tissue fibrosis
13%
Dermatitis radiation
12%
Sore throat
7%
Hypothyroidism
7%
Neck edema
7%
Aspiration
5%
Dehydration
5%
Other Gastrointestinal disorders
5%
Hoarseness
5%
Nausea
5%
Weight loss
3%
Other Musculoskeletal and connective tissue disorder
3%
Laryngeal edema
3%
Pain
3%
Depression
3%
Edema face
3%
Oral pain
3%
Trismus
2%
Other Nervous system disorders
2%
Constipation
2%
Dizziness
2%
Anxiety
2%
Lip pain
2%
Other Ear and labyrinth disorders
2%
Hypoxia
2%
Other General disorders and administration site conditions
2%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm Phase 2
Awards & Highlights
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.
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
~6550
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for oropharyngeal cancer include radiation therapy and chemoradiation. Radiation therapy works by using high-energy rays to target and destroy cancer cells, while minimizing damage to surrounding healthy tissue.
Chemoradiation combines radiation therapy with chemotherapy, which uses drugs like cisplatin to enhance the cancer-killing effects of radiation. This combination is particularly effective for high-risk patients, as it improves locoregional control and overall survival.
The significance of these treatments for oropharyngeal cancer patients lies in their ability to effectively manage the disease while potentially reducing long-term side effects. Studies on less intense radiation therapy aim to maintain treatment efficacy while minimizing toxicity, improving quality of life for patients.
Overall treatment time and the conventional arm of the CHART trial in the radiotherapy of head and neck cancer.New classification of stage IV squamous cell carcinoma of the oropharynx.
Overall treatment time and the conventional arm of the CHART trial in the radiotherapy of head and neck cancer.New classification of stage IV squamous cell carcinoma of the oropharynx.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,318 Previous Clinical Trials
2,950,804 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.
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