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Radiation Therapy

Radiation Therapy for Head and Neck Cancer

Phase 2

Recruiting

Led By Jack Phan

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients with histologically documented recurrent head and neck cancer, or second primary head and neck cancer, AND who have previously received radiation (at least 30 Gy) for head and neck cancer

Not eligible for surgery for recurrence or poor surgical candidate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 2 years

Awards & highlights

Study Summary

This trial is testing two types of radiation therapy to see which is more effective in treating head and neck cancer that has returned.

Who is the study for?

This trial is for adults with head and neck cancer that has returned after treatment. They should be in a condition to undergo radiation (ECOG score 0-2), not pregnant, and have had previous radiation of at least 30 Gy. Candidates must not be suitable for surgery, have visible tumors on scans, and limited sites of recurrence.Check my eligibility

What is being tested?

The study compares two advanced types of radiation therapy: Stereotactic Body Radiation Therapy (SBRT) which targets tumors precisely with fewer sessions, and Intensity Modulated Radiation/Proton Therapy (IMRT/PRT) which uses high-energy rays or protons to kill tumor cells.See study design

What are the potential side effects?

Potential side effects include skin reactions, fatigue, dry mouth or throat issues due to damage to surrounding tissues; difficulty swallowing; changes in taste; nausea; inflammation from precise but intense radiation doses.

Eligibility Criteria

Inclusion Criteria

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

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I have had head and neck cancer before, received radiation, and it has come back or I have a new one.

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I cannot have surgery for my cancer's return due to high risks.

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My cancer has returned in 1-3 places, each smaller than 60 cc and all together under 100 cc.

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I can take care of myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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

Incidence of grade 3+ toxicity (Tox3+) assessed by Common Terminology Criteria for Adverse Events (CTCAE)

Secondary outcome measures

Incidence of acute grade 3 or higher toxicity assessed by CTCAE

Incidence of late grade 3 or higher toxicity assessed by CTCAE

Local control defined as absence of local failure

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group II (IMRT/IMPT)Experimental Treatment2 Interventions

Patients undergo IMRT/IMPT once daily (Monday-Friday) for up to 30-35 treatments.

Group II: Group I (SBRT)Experimental Treatment1 Intervention

Patients undergo SBRT every other day for a total of 5 treatments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity-Modulated Radiation Therapy

2010

Completed Phase 3

~2160

Proton Radiation

2009

N/A

~170

Stereotactic Body Radiation Therapy

2012

Completed Phase 2

~780

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,973 Previous Clinical Trials

1,789,261 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,926,098 Total Patients Enrolled

Jack PhanPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

Frequently Asked Questions

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

Are patients still being enrolled in this research project?

"Yes, the clinicaltrial.gov website indicates that this study is ongoing and actively recruiting patients. The listing was first published on May 22nd, 2017 with the most recent update happening on August 16th, 2022."

Answered by AI

How many research subjects are involved in this investigation?

"Yes, the information provided on clinicaltrials.gov reveals that this trial is still recruiting patients. This study was originally posted on 5/22/2017 and was last updated on 8/16/2022. They are currently looking for 100 more participants at 1 location."

Answered by AI

What are some risks associated with Intensity-Modulated Radiation Therapy?

"Intensity-Modulated Radiation Therapy currently has a score of 2. This is because, while there is some evidence affirming its safety, there is no data to support how effective the treatment actually is."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer

2017. "Stereotactic Body Radiation Therapy or Intensity Modulated Radiation/Proton Therapy in Treating Patients With Recurrent Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03164460.