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Radiation

Radiotherapy for Head and Neck Cancer (HN-Bio 02 Trial)

N/A

Waitlist Available

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

Age >/= 18 years

Must not have

Non-reversible clotting abnormality

Previous solid tumor treated within last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effects of radiation therapy on biomarkers in patients with newly diagnosed head and neck cancer who are undergoing curative treatment. It is part of a larger study called the HN-B

Who is the study for?

This trial is for individuals with newly diagnosed head and neck squamous cell carcinoma (HNSCC) who are about to receive curative radiation therapy. Specific eligibility criteria details were not provided, so it's best to contact the study organizers for more information.

What is being tested?

The study explores how standard external beam radiotherapy affects biomarker development in HNSCC patients. It compares two methods: a single integrated boost versus a two-phase treatment approach.

What are the potential side effects?

While specific side effects aren't listed, external beam radiotherapy can generally cause skin reactions, fatigue, dry mouth, difficulty swallowing, and changes in taste.

Eligibility Criteria

Inclusion Criteria

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

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I am able to get out of my bed or chair and move around.

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I am 18 years old or older.

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My cancer is a type of squamous cell carcinoma located in the head or neck.

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My cancer or its spread is larger than 3cm.

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My kidneys are working well enough (creatinine clearance is 30ml/min or more).

Exclusion Criteria

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

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My blood does not clot properly and it cannot be corrected.

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I was treated for another type of cancer within the last 5 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Assess changes in tumor microenvironment during differing radiotherapy scheduling via repeat biopsy.

Change in fMRI during radiotherapy

Confirm feasibility of recruitment of HN patients for on treatment repeat biopsy of the primary tumor +/- neck nodes

Secondary study objectives

Validate novel and established fMRI imaging as predictive and prognostic radiotherapy biomarkers for HNSCC

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Active Control

Group I: Arm 1: Integrated Boost RadiotherapyActive Control1 Intervention

External beam radiotherapy 70Gy in 35 fractions to head and neck tumour and 56 Gy in 35 fraction to elective nodal regions. This will be given as single integrated boost or two-phase treatment at clinician discretion.

Group II: Arm 2: Two Phase RadiotherapyActive Control1 Intervention

Standard of care external beam radiotherapy 70 Gy in 35 fractions to head and neck with delayed 40 Gy in 20 fractions to elective nodal regions. This will be given as reversed two-phase treatment.

0 / 7Eligibility criteria met