What side effects are associated with this type of intervention?

Common treatments for oropharyngeal cancer, such as standard-dose radiation therapy and concurrent chemoradiation, often result in significant side effects including mucositis, dysphagia, xerostomia, and the need for tube feeding. High-dose radiation therapy can lead to severe late toxicities like fibrosis, soft tissue necrosis, and osteonecrosis. In contrast, less intense radiation therapy, which uses a reduced dose over a shorter duration, has been associated with fewer severe adverse events, improved swallowing function, and better overall quality of life, though it may still cause some degree of mucositis and xerostomia.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of oropharyngeal cancer have included traditional radiation therapy and chemoradiotherapy regimens. Standard treatments often involve high-dose radiation over extended periods, typically six weeks. However, recent studies have explored less intense radiation treatments, such as reduced radiation doses administered over shorter durations, similar to the trial investigating a two-week radiation course. Additionally, drugs like cisplatin and cetuximab have been used concurrently with radiation therapy to enhance treatment efficacy. These approaches aim to maintain treatment effectiveness while reducing long-term toxicity and improving quality of life for patients.

What other types of research exist?

Promising novel alternatives to less intense radiation therapy for oropharyngeal cancer patients include: 1) Proton therapy, which offers reduced toxicity compared to traditional photon therapy. 2) Stereotactic body radiation therapy (SBRT), which provides precise, high-dose radiation over fewer sessions. 3) Combination therapies such as pembrolizumab plus cetuximab, which have shown efficacy in recurrent or metastatic cases. 4) Metronomic chemotherapy, which uses frequent, lower doses of chemotherapy to minimize toxicity and target tumor angiogenesis.

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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

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 more

Side effects data

From 2018 Phase 2 trial • 60 Patients • NCT02159703

67%

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

Hypothyroidism

Neck edema

Aspiration

Dehydration

Other Gastrointestinal disorders

Hoarseness

Nausea

Weight loss

Other Musculoskeletal and connective tissue disorder

Laryngeal edema

Pain

Depression

Edema face

Oral pain

Trismus

Other Nervous system disorders

Constipation

Dizziness

Anxiety

Lip pain

Other Ear and labyrinth disorders

Hypoxia

Other General disorders and administration site conditions

Vomiting

100%

80%

60%

40%

20%

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

0 / 23Eligibility criteria met

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.