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SPECT-CT Guided Radiation for Oropharyngeal Cancer (SELECT Trial)

Phase 3

Recruiting

Research Sponsored by Canadian Cancer Trials Group

Eligibility Criteria Checklist

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

Must have

Intent to deliver concurrent chemotherapy or not must be known at the time of randomization

Clinical stage T1-3 M0 (UICC/AJCC TNM 8th Edition). Nodal involvement may include no nodes or single or multiple ipsilateral lymph nodes (largest ≤6cm in maximum diameter)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 years

Awards & highlights

SELECT Trial Summary

This trialis testing if using imaging to guide radiation therapy to one side of the neck can reduce risk of cancer returning or spreading.

Who is the study for?

This trial is for individuals with lateralized oropharyngeal cancer (OPC) that hasn't spread across the midline, regardless of HPV status. Participants must have had recent imaging tests and be planning to receive radiotherapy (RT) on both sides of the neck, with or without chemotherapy. They should be in a condition to complete treatment and follow-ups, willing to use effective contraception if applicable, and able to provide tumor tissue samples. People who've had certain previous treatments or severe health issues are excluded.Check my eligibility

What is being tested?

The study aims to determine if using SPECT-CT guided lymphatic mapping for directing radiotherapy only where necessary is as effective at preventing cancer spread or return as the usual approach of treating both sides of the neck. Patients will either receive this new targeted treatment method or undergo standard bilateral neck radiotherapy.See study design

What are the potential side effects?

While specific side effects aren't listed here, potential risks may include those commonly associated with radiation therapy such as skin irritation, sore throat, difficulty swallowing, dry mouth, fatigue and possibly more depending on individual patient factors.

SELECT Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I know if I'll receive chemotherapy at the same time as another treatment.

Select...

My cancer is in an early stage and hasn't spread far.

Select...

My cancer is in one side of my throat and hasn't spread across the middle.

Select...

My cancer is either HPV positive or negative.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Select...

I am scheduled for radiation therapy on both sides of my neck.

SELECT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 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

Distant Metastases (DM)

Financial Toxicity [Financial Index of Toxicity (FIT)]

Gastrostomy Tube Usage

+10 more

SELECT Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Lympathic Mapping with SPECT-CT guided RadiotherapyExperimental Treatment1 Intervention

Group II: Bilateral Neck RadiotherapyActive Control1 Intervention

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupNETWORK

388 Previous Clinical Trials

261,301 Total Patients Enrolled

SWOG Cancer Research NetworkNETWORK

394 Previous Clinical Trials

264,660 Total Patients Enrolled

NRG OncologyOTHER

231 Previous Clinical Trials

100,342 Total Patients Enrolled

Media Library

Ipsilateral and Contralateral Neck Clinical Trial Eligibility Overview. Trial Name: NCT05451004 — Phase 3

Oropharyngeal Cancer Research Study Groups: Lympathic Mapping with SPECT-CT guided Radiotherapy, Bilateral Neck Radiotherapy

Oropharyngeal Cancer Clinical Trial 2023: Ipsilateral and Contralateral Neck Highlights & Side Effects. Trial Name: NCT05451004 — Phase 3

Ipsilateral and Contralateral Neck 2023 Treatment Timeline for Medical Study. Trial Name: NCT05451004 — Phase 3

Frequently Asked Questions

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

Has the FDA issued authorization for Lympathic Mapping with SPECT-CT guided Radiotherapy?

"There is prior clinical evidence that supports the saftey of Lympathic Mapping with SPECT-CT guided Radiotherapy, thus it was rated a 3 on our scale."

Answered by AI

What is the enrollment size of this experiment?

"Affirmative. Clinicaltrials.gov has information that this research is currently recruiting, having been posted on September 29th 2022 and updated as recently as February 3rd 2023. The medical experiment seeks to enrol 510 participants from a single site."

Answered by AI

Is enrollment into this experiment currently open to participants?

"Affirmative. As denoted on clinicaltrials.gov, this research was first made public in September 2022 and recently updated in February 2023. The study is enrolling 510 volunteers at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer

2023. "SPECT-CT Guided ELEctive Contralateral Neck Treatment for Patients With Lateralized Oropharyngeal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05451004.