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Radiation Therapy

Reduced Intensity Radiation for Head and Neck Cancer

Phase 2

Waitlist Available

Led By Wade Thorstad, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

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

Must have

Patients with pathologically proven tumors of the oral cavity, oropharynx, larynx, or hypopharynx treated with surgical resection with one (or both) side(s) of the neck pathologically N0

Indication for radiation therapy at the primary site or neck with specific characteristics including close margin (<= 0.5 cm), positive margin, perineural invasion, lymphovascular space invasion, metastatic disease in more than one lymph node, metastatic disease in more than one lymph node group, extracapsular extension in any lymph node, or considered at risk based on multi-disciplinary tumor board discussion

Must not have

Previous head and neck surgery

Previous head and neck cancer other than non melanoma skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up completion of follow-up (minimum of 5 years from completion of treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether reducing radiation to parts of the neck without cancer can help spare side effects from radiation for head and neck cancer.

Who is the study for?

This trial is for adults over 18 with certain types of head and neck cancer, specifically in the oral cavity, oropharynx, larynx, or hypopharynx. They should have had surgery already and show no signs of cancer on one or both sides of their neck. The trial isn't open to those who've had previous head and neck cancers (except non-melanoma skin cancer), prior head and neck surgeries, or women who are pregnant or nursing.

What is being tested?

The study is testing whether reducing radiation therapy to areas without evident cancer can lessen side effects for patients with head and neck cancer. It involves adjusting the amount of radiation away from healthy tissue after surgical removal of tumors.

What are the potential side effects?

While not explicitly listed here, common side effects from intensity modulated radiation therapy may include skin changes similar to sunburns, fatigue, dry mouth/throat issues due to less saliva production, difficulty swallowing, taste changes, and potential dental problems.

Eligibility Criteria

Inclusion Criteria

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

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My cancer in the mouth or throat was surgically removed and did not spread to my neck.

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I need radiation therapy due to certain high-risk features of my cancer.

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I am 18 years old or older.

Exclusion Criteria

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

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I have had surgery on my head or neck before.

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I have had head and neck cancer before, but not skin cancer.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ completion of follow-up (minimum of 5 years from completion of treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~completion of follow-up (minimum of 5 years from completion of treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of follow-up (minimum of 5 years from completion of treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With a Recurrence in the Unirradiated Neck(s)

Secondary study objectives

Kaplan Meier Estimate of Locoregional Recurrence Free Survival

Patterns of Failure Associated With Implementation of Primary Objective

Quality of Life (QOL) as Measured by Overall Global QOL Scores

+1 more

Side effects data

From 2016 Phase 2 trial • 68 Patients • NCT00057785

90%

Dry mouth

87%

Salivary gland disorder NOS

75%

Hemoglobin decreased

75%

Late RT toxicity: Salivary gland: NOS

74%

Radiation mucositis

74%

Fatigue

74%

Leukopenia NOS

68%

Nausea

63%

Dermatitis radiation NOS

60%

Late RT toxicity: Mucous membrane: NOS

59%

Weight decreased

49%

Hearing impaired

49%

Late RT toxicity: Other: NOS

49%

Neutropenia

47%

Late RT toxicity: Auditory/hearing: NOS

46%

Vomiting NOS

41%

Esophagitis NOS

41%

Late RT toxicity: Esophagus: NOS

40%

Late RT toxicity: Subcutaneous tissue (within RT field): NOS

38%

Hyponatremia

35%

Pain-other

35%

Dysphagia

35%

Pain due to radiation

34%

Peripheral sensory neuropathy

32%

Late RT toxicity: Skin (within RT field): NOS

29%

Alopecia

28%

Dehydration

28%

Blood albumin decreased

28%

Taste disturbance

26%

Platelet count decreased

26%

Anorexia

25%

Hypocalcemia

25%

Hearing-Other

24%

Hyperglycemia NOS

24%

Lymphopenia

22%

Hypokalemia

22%

Stomatitis

22%

Blood magnesium decreased

22%

Epistaxis

21%

Constipation

19%

Late RT toxicity: Joint: NOS

19%

Edema NOS

19%

Renal/GU-Other

19%

Late RT toxicity: Larynx: NOS

19%

Alanine aminotransferase increased

18%

Blood creatinine increased

16%

Cough

15%

Hypothyroidism

15%

Pyrexia

15%

Headache NOS

13%

Diarrhea NOS

13%

Skin discoloration

13%

Aspartate aminotransferase increased

13%

Blood alkaline phosphatase NOS increased

12%

Hematologic-Other

12%

GI-other

12%

Skin-Other

10%

Hyperkalemia

10%

Metabolic-Other

10%

Otitis media serous NOS

10%

Infection NOS

Hypophosphatemia

Esophageal spasm

Hypotension NOS

Blood bilirubin increased

Peripheral motor neuropathy

Dyspnea NOS

Dermatitis exfoliative NOS

Erythema multiforme

Rigors

Gamma-glutamyltransferase increased

Dysphonia

Hiccups

Rhinitis allergic NOS

Late RT toxicity: Bone (incl. osteonecrosis): NOS

Packed red blood cell transfusion

Infection with grade 3 or 4 neutropenia

Earache

Dizziness (exc vertigo)

Neuralgia NOS

Confusion

Insomnia NEC

Pulmonary-other

Toxicoderma

Joint, muscle, or bone-Other

Febrile neutropenia

Syncope

Hypoxia

Pneumonitis NOS

Otitis externa (exc boil of meatus) NOS

Endocrine-Other

Infection, Other

Hallucination NOS

Sinus tachycardia

Supraventricular arrhythmia NOS

Ventricular arrhythmia NOS

Implant infection

Infection with unknown ANC

CD4 lymphocytes decreased

Inappropriate ADH secretion

Leukocytes for BMT

Weight increased

Acidosis NOS

Tumour pain

Neurologic-Other

Hemorrhage NOS

Thrombosis NOS

Left ventricular failure

Anxiety NEC

Depression NEC

Renal failure NOS

100%

80%

60%

40%

20%

Study treatment Arm

IMRT +/- Chemotherapy

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intensity modulated radiation therapy (IMRT)Experimental Treatment1 Intervention

-This study provides guidelines for volume to be contoured during IMRT based on tumor site and stage of tumor site. The clinical tumor volume (CTV)1 will be treated to 66 Cy in 33 fractions or 60 Gy in 30 fractions. The CTV2 will be treated to 54 Gy in 33 fractions or 52 Gy in 30 fractions. The CTV3 will be modified based on tumor site and stage of tumor site in order to reduce volume.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity modulated radiation therapy

2003

Completed Phase 2

~140

0 / 6Eligibility criteria met