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Radiation Therapy

Reduced-Dose Radiation Therapy for Head and Neck Cancer

N/A

Recruiting

Led By Danielle N. Margalit, MD, MPH

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed squamous cell carcinoma of the tonsil or base of tongue (oropharynx) or unknown primary with p16-positive cervical lymph node metastases

Normal organ and marrow function as defined below: leukocytes ≥3,000/mcL, absolute neutrophil count ≥1,000/mcL, platelets ≥100,000/mcL, total bilirubin within normal institutional limits, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, creatinine ≤ 1.5 times the institutional upper limit of normal OR creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.

Must not have

Pregnant women are excluded from this study because of the teratogenic risks of radiation exposure to the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation therapy and supportive care medications required for symptomatic management of head and neck cancer side effects as well as general anesthesia required for oncologic head and neck surgery, breastfeeding should be discontinued if the mother is enrolled in the study. Pregnancy status will be determined by a serum pregnancy test.

Prior head and neck radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a lower dose of radiation and chemo after surgery to see if it decreases side effects and improves quality of life.

Who is the study for?

This trial is for adults who've had surgery for HPV-related squamous cell carcinoma of the throat, with a history of light or no smoking (≤20 pack-years), good performance status, and no prior head and neck cancer or radiation. They must have normal organ function and no serious illnesses that could affect study participation.

What is being tested?

The study tests whether a lower dose of postoperative radiation therapy can reduce side effects while still being effective against HPV-associated oropharyngeal squamous cell carcinoma. It aims to improve quality of life after treatment.

What are the potential side effects?

Potential side effects include skin irritation, dry mouth, difficulty swallowing, changes in taste, fatigue, and possibly long-term impacts on salivary glands and oral health due to the reduced intensity of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of throat cancer that's p16 positive.

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My blood tests show normal organ function and healthy blood cell counts.

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I have smoked 20 or fewer pack-years of cigarettes.

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My cancer has not spread to distant parts of my body.

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I am a candidate for surgery aimed at curing my condition, expected to remove all cancer.

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I am fully active or able to carry out light work.

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My cancer has not spread to many lymph nodes.

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My cancer has not spread to distant parts of my body.

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I am 18 years old or older.

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I am 18 years old or older.

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My kidney function is within the normal range or slightly above.

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My cancer is in an early stage (T0, T1, or T2).

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I have smoked 20 or fewer pack-years of cigarettes.

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My tumor is HPV-related, confirmed by specific tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding if I want to join this study.

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I have had radiation therapy on my head or neck before.

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My lymph nodes are swollen and stuck together.

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

Disease-free survival

Secondary study objectives

Dysphagia

Overall Survival

Quality Of Life Questionnaire

+3 more

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054

78%

Menopausal symptoms

60%

Urinary frequency

52%

Impotence

47%

Late RT Toxicity: Bladder: NOS

39%

Diarrhea NOS

27%

Late RT Toxicity: Bowel: NOS

26%

Fatigue

26%

Late RT Toxicity: Other GU: NOS

21%

Proctitis NOS

21%

Dysuria

14%

Libido decreased

14%

Dermatitis radiation NOS

12%

Late RT Toxicity: Other: NOS

12%

Late RT Toxicity: Other GI: NOS

12%

Hemoglobin decreased

12%

Alanine aminotransferase increased

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Depression NEC

Nausea

Hyperglycemia NOS

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Platelet count decreased

Hyponatremia

Hypocalcemia

Blood albumin decreased

Stomatitis

Weight decreased

Anorexia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Low RiskExperimental Treatment1 Intervention

Observation without adjuvant therapy * Pathologic T0-2, N0-1 * Minimum of 15 lymph nodes retrieved on neck dissection per dissected side of the neck * Single positive lymph node up to 3cm * No extranodal extension * Clear margins

Group II: Intermediate RiskExperimental Treatment1 Intervention

Reduced-dose radiation (46Gy) * Pathologic T0-2N0-2 and any one of the following features: * 2 or more positive lymph nodes * single node \>3cm * \<15 lymph nodes retrieved on neck dissection for each side of the neck * Positive lymph nodes in level IB, IV, or V -≤1mm extranodal extension * Positive lymph node(s) contralateral to the primary tumor * Close margins

Group III: High RiskExperimental Treatment1 Intervention

Postoperative radiation (60Gy) without chemotherapy * Pathologic T0-4N0-2 and any one of the following features: -\>1mm extranodal extension * Microscopic positive margins

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation therapy

2013

Completed Phase 3

~2850

0 / 17Eligibility criteria met