SPECT-CT Guided Radiation for Oropharyngeal Cancer

(SELECT Trial)

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Canadian Cancer Trials Group

Disqualifiers: Previous head/neck cancer, COPD, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study is being done to answer the following question: Is the chance of cancer spreading or returning the same if radiotherapy to the neck is guided, by using a special imaging study called lymph node mapping (lymphatic mapping) Single Photon Emission Computed Tomography (SPECT-CT), compared to the usual treatment when radiotherapy is given to both sides of the neck?

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment SPECT-CT Guided Radiation for Oropharyngeal Cancer?

Research suggests that using SPECT-CT (a type of imaging that combines two different scans) to guide radiation treatment for oropharyngeal cancer can help target the cancer more precisely. This approach may reduce unnecessary radiation to healthy areas, potentially lowering side effects and improving quality of life for patients. ^{1 2 3 4 5}

Is SPECT-CT guided radiation safe for humans?

Research suggests that using SPECT-CT for guiding radiation treatment in head and neck cancers can reduce unnecessary radiation exposure, which may lower the risk of side effects and improve quality of life. This indicates a favorable safety profile for this approach in humans. ^{1 2 5 6 7}

How is SPECT-CT guided radiation treatment for oropharyngeal cancer different from other treatments?

SPECT-CT guided radiation treatment for oropharyngeal cancer is unique because it uses advanced imaging to map lymphatic drainage, allowing for more precise targeting of radiation to affected areas and potentially reducing unnecessary radiation exposure to healthy tissue, which can lower side effects and improve quality of life. ^{1 2 4 5 7}

Research Team

John R de Almeida

Principal Investigator

University Health Network, Princess Margaret Hospital, Toronto ON Canada

Ali Hosni

Principal Investigator

University Health Network, Princess Margaret Hospital, Toronto ON Canada

Eligibility Criteria

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.

Inclusion Criteria

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

Radiological investigations within 8 weeks of registration: CT or MRI of the neck (with head imaging as indicated), PET-CT scan, Chest CT scan

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

Exclusion Criteria

Radiotracer allergy

I have had initial chemotherapy before surgery.

My cancer is only in the tonsil area, with no or one small nearby lymph node affected.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive radiotherapy guided by SPECT-CT or bilateral neck radiotherapy

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Participants' quality of life and other outcomes are assessed over 8 years

8 years

Treatment Details

Interventions

• Ipsilateral and Contralateral Neck (Radiation)
• Lymphatic Mapping with SPECT-CT (Procedure)

Trial Overview 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.

Participant Groups

Group I: Lympathic Mapping with SPECT-CT guided Radiotherapy Experimental Treatment 1 Intervention

Group II: Bilateral Neck Radiotherapy Active Control 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson in Sugar Land Sugar Land, TX

City of Hope Comprehensive Cancer Center Duarte, CA

Moffitt Cancer Center - McKinley Campus Tampa, FL

Providence Portland Medical Center Portland, OR

More Trial Locations

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Patients Recruited

70,300+

Southwest Oncology Group

Collaborator

Trials

389

Patients Recruited

260,000+

SWOG Cancer Research Network

Collaborator

Trials

403

Patients Recruited

267,000+

NRG Oncology

Collaborator

Trials

242

Patients Recruited

105,000+

Alliance for Clinical Trials in Oncology

Collaborator

Trials

521

Patients Recruited

224,000+

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Patients Recruited

153,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lymphatic mapping with SPECT-CT for evaluation of contralateral drainage in lateralized oropharyngeal cancers using an awake injection technique. Thomas, CM., Khan, MN., Mohan, R., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SPECT/CT-guided elective nodal irradiation for head and neck cancer: Estimation of clinical benefits using NTCP models. de Veij Mestdagh, PD., Janssen, T., Lamers, E., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SPECT/CT-guided lymph drainage mapping for the planning of unilateral elective nodal irradiation in head and neck squamous cell carcinoma. de Veij Mestdagh, PD., Jonker, MCJ., Vogel, WV., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unilateral versus bilateral nodal irradiation: Current evidence in the treatment of squamous cell carcinoma of the head and neck. Nuyts, S., Bollen, H., Eisbruch, A., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating contralateral neck failure in patients with lateralized OPSCC treated with transoral robotic surgery and neck management based on pre-operative SPECT-CT lymphatic mapping. Berania, I., Hosni, A., Thomas, CM., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elective unilateral nodal irradiation in head and neck squamous cell carcinoma: A paradigm shift. Al-Mamgani, A., Verheij, M., van den Brekel, MWM.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omitting Elective Irradiation of the Contralateral Retropharyngeal Nodes in Oropharyngeal Squamous Cell Carcinoma Treated with Intensity-modulated Radiotherapy. Nagatsuka, M., Hughes, RT., Shenker, RF., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lymphatic mapping with SPECT-CT for evaluation of contralateral drainage in lateralized oropharyngeal cancers using an awake injection technique. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

SPECT/CT-guided elective nodal irradiation for head and neck cancer: Estimation of clinical benefits using NTCP models. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

SPECT/CT-guided lymph drainage mapping for the planning of unilateral elective nodal irradiation in head and neck squamous cell carcinoma. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Unilateral versus bilateral nodal irradiation: Current evidence in the treatment of squamous cell carcinoma of the head and neck. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating contralateral neck failure in patients with lateralized OPSCC treated with transoral robotic surgery and neck management based on pre-operative SPECT-CT lymphatic mapping. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Elective unilateral nodal irradiation in head and neck squamous cell carcinoma: A paradigm shift. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Omitting Elective Irradiation of the Contralateral Retropharyngeal Nodes in Oropharyngeal Squamous Cell Carcinoma Treated with Intensity-modulated Radiotherapy. [2020]