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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease-free survival

Secondary outcome measures

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 GI: NOS

12%

Late RT Toxicity: Other: 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

Nausea

Hyperglycemia NOS

Depression NEC

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Stomatitis

Platelet count decreased

Blood albumin decreased

Weight decreased

Anorexia

Hypocalcemia

Hyponatremia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

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 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,869 Total Patients Enrolled

Danielle N. Margalit, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

De_Intensified Postoperative Radiation Therapy (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03875716 — N/A

Head and Neck Cancers Research Study Groups: Intermediate Risk, High Risk, Low Risk

Head and Neck Cancers Clinical Trial 2023: De_Intensified Postoperative Radiation Therapy Highlights & Side Effects. Trial Name: NCT03875716 — N/A

De_Intensified Postoperative Radiation Therapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03875716 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for individuals to participate in this clinical investigation?

"According to clinicaltrials.gov, this experiment is recruiting patients right now. It was initially published on May 20th 2019 and most recently updated on February 14th 2022."

Answered by AI

What is the maximum capacity of participants for this research endeavor?

"Yes, the information publicly available on clinicaltrials.gov affirms that this trial is still actively seeking participants as of February 14th 2022. This research was originally posted in May 20th 2019 and requires 111 individuals to be recruited from a single centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma

Danielle Margalit, MD, MPH 2019. "Study of De_Intensified Postoperative Radiation Therapy for HPV Associated Oropharyngeal Squamous Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03875716.

All > Squamous Cell Carcinoma