SPECT-CT Guided Radiation for Oropharyngeal Cancer

(SELECT Trial)

Recruiting at 32 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special imaging technique called SPECT-CT can guide neck radiation to prevent the spread or return of oropharyngeal cancer as effectively as the usual method of treating both sides of the neck. It compares two approaches: targeted radiotherapy guided by imaging (Ipsilateral and Contralateral Neck) and treatment of both sides of the neck. Suitable participants have oropharyngeal cancer confined to the neck area and plan to start radiation treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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 prior data suggests that SPECT-CT guided radiotherapy is safe for oropharyngeal cancer treatment?

Research has shown that lymphatic mapping with SPECT-CT is safe for patients. One study found this method reliable and low-risk. Patients at several hospitals have safely used this type of lymphatic mapping for throat cancer. Another study confirmed its safety and consistent application.

These findings suggest the treatment is well-tolerated, with no major side effects reported. This provides confidence in the safety of trying this new approach in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SPECT-CT guided radiation for oropharyngeal cancer because it offers a more targeted approach to radiotherapy. Unlike standard treatments that typically involve broad radiation to both sides of the neck, this method uses advanced imaging to map lymph nodes, allowing for precise radiation delivery only where it's needed. This technique aims to reduce damage to healthy tissue and minimize side effects, potentially enhancing the quality of life for patients. By focusing radiation more accurately, there's hope for better outcomes and fewer treatment-related complications.

What evidence suggests that SPECT-CT guided radiotherapy is effective for oropharyngeal cancer?

Research has shown that a special imaging technique called SPECT-CT can accurately track how oropharyngeal cancer spreads to the lymph nodes. This method helps doctors target the exact areas needing radiation, reducing unnecessary treatment on healthy tissue. In this trial, one group of participants will receive Lymphatic Mapping with SPECT-CT guided Radiotherapy, while another group will receive Bilateral Neck Radiotherapy. Studies have found that the focused approach using SPECT-CT effectively manages cancer while reducing side effects. Additionally, guiding radiotherapy with SPECT-CT might lower the risk of cancer recurrence or spread compared to traditional methods. These findings suggest promising results for patients, making it a strong option for effective treatment. ^{1 2 3 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3065910/

SPECT/CT for Lymphatic Mapping of Sentinel Nodes in Early ... SPECT/CT is recommended to be used routinely, although SPECT/CT is not indispensable for successful SNB. 1. Background. Squamous cell carcinoma of the oral ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/hed.27871

A multi‐institutional feasibility lead‐in trial of lymphatic ... Lymphatic mapping with SPECT–CT has been demonstrated to accurately define lymphatic drainage patterns in oropharyngeal cancer but there has ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05451004?term=AREA%5BNCTIdSearch%5D(NCT05451004)&rank=1

SPECT-CT Guided ELEctive Contralateral Neck Treatment ... 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, ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31778005/

Lymphatic mapping with SPECT-CT for evaluation of ... We propose lymphatic mapping with single photon emission computed tomography (SPECT-CT) for tumor-specific delineation of lymphatic drainage to guide treatment.

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-019-6331-8

Mapping of sentinel lymph node drainage using SPECT ... This trial aims to minimize the proportion of patients that undergo bilateral ENI, by using lymph drainage mapping by SPECT/CT to select ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6857144/

Mapping of sentinel lymph node drainage using SPECT/CT ... In this one-armed, single-center prospective trial, patients with primary T1-4 N0-2b HNSCC of the oral cavity, oropharynx, larynx (except T1 glottic) or ...

7. asco.org asco.org/abstracts-presentations/ABSTRACT417542

CCTG HN11: SPECT-CT guided elective contralateral neck ... Background: Lymphatic mapping identifies neck lymph nodes at risk for cancer spread in patients with lateralized oropharyngeal (OPC) squamous cell carcinoma ...