SPECT-CT Guided Radiation for Oropharyngeal Cancer

(SELECT Trial)

Recruiting at 26 trial locations

Overseen By Wendy Parulekar

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Canadian Cancer Trials Group

Disqualifiers: Previous head/neck cancer, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

510 Participants Needed

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.

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
• Lymphatic Mapping with SPECT-CT

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

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Southwest Oncology Group

Collaborator

Trials

389

Recruited

260,000+

SWOG Cancer Research Network

Collaborator

Trials

403

Recruited

267,000+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

Alliance for Clinical Trials in Oncology

Collaborator

Trials

521

Recruited

224,000+

Eastern Cooperative Oncology Group

Collaborator

Trials

272

Recruited

153,000+

Findings from Research

Lymphatic mapping using SPECT-CT with a nonoperative injection of 99m-Tc sulfur colloid is a feasible method for characterizing lymphatic drainage in patients with oropharyngeal squamous cell carcinoma (OPSCC), as demonstrated in a study of 10 patients.

The study found that contralateral lymphatic drainage is rare, with 90% of patients showing satisfactory radiotracer migration primarily to the ipsilateral neck, suggesting that treatment strategies may need to be adjusted based on these findings.

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]

Using SPECT/CT-guided lymph drainage mapping for unilateral elective nodal irradiation (ENI) in 40 patients with head and neck squamous cell carcinoma significantly reduced radiation doses to critical organs, such as the contralateral parotid gland and thyroid gland, by up to 27.3 Gy.

This approach also led to notable reductions in the risk of radiation-related side effects, such as xerostomia and dysphagia, improving the overall quality of life for patients undergoing treatment.

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]

Lymph drainage mapping (LDM) using SPECT/CT was successfully performed in 54 out of 55 head and neck cancer patients, demonstrating a high feasibility rate of 98%.

In 20% of patients, contralateral lymph drainage was observed, particularly in T3 tumors, suggesting that selective unilateral elective neck irradiation could reduce unnecessary radiation exposure and improve quality of life for patients without contralateral drainage.

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]

Recent advancements in diagnostic imaging have improved the accuracy of nodal staging in head and neck cancers, suggesting that smaller, more targeted radiation volumes may be sufficient, potentially reducing unnecessary treatment of healthy tissue.

There is a growing interest in unilateral nodal irradiation as a less toxic alternative to the traditional bilateral approach, which may help minimize treatment-related side effects while still effectively targeting cancerous nodes.

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]

In a study of 13 patients with early-stage oropharyngeal squamous cell carcinoma (OPSCC), pre-operative lymphatic mapping using SPECT-CT showed that 92.3% had only ipsilateral drainage, suggesting that many patients may not need bilateral neck treatment.

All patients remained disease-free at a median follow-up of 15.4 months, indicating that targeted treatment based on lymphatic mapping does not compromise oncological outcomes while potentially reducing unnecessary treatment.

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]

A review of 11 studies involving 1116 patients with head and neck squamous cell carcinoma (HNSCC) found that the incidence of contralateral regional failure (cRF) is very low (2.4%) when treating oropharyngeal cancer with unilateral neck irradiation, suggesting that many patients may be overtreated.

For patients with lateralized tumors that do not cross the midline, a more selective approach to unilateral elective nodal irradiation could reduce unnecessary radiation exposure and improve quality of life, supported by advancements in diagnostic imaging techniques.

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]

In a study of 54 patients with unilateral oropharyngeal cancer, omitting radiation treatment to the contralateral retropharyngeal lymph nodes (RPLN) did not lead to any failures in those nodes, indicating that this approach is safe.

There were no significant differences in local, regional, or distant failure rates between patients who received treatment to the contralateral RPLN and those who did not, suggesting that sparing these nodes does not compromise disease control.

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]