36 Participants NeededMy employer runs this trial

Active Surveillance for Throat Cancer

HC
Overseen ByHCC Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical University of South Carolina
Must be taking: Platinum chemotherapy
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether some throat cancer patients can safely skip radiation after surgery. It targets those with HPV-related oropharyngeal cancer who show no signs of the virus in their blood post-surgery. The researchers aim to monitor these patients closely using Active Surveillance With ctHPVDNA (NavDx®) to detect any recurrence early, avoiding the side effects of radiation. Patients with HPV-related throat cancer who have undergone surgery might be suitable candidates, particularly if they are not currently smoking. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication. It's best to discuss your specific medications with the trial team.

What prior data suggests that this active surveillance method is safe for patients with HPV-OPSCC?

Studies have shown that ctHPVDNA testing, used to monitor HPV-related throat cancer, can detect cancer recurrence earlier than traditional methods. This early detection plays a crucial role in effective disease management. Research indicates that patients generally find this method easy to handle, as it relies on blood tests instead of treatments that often cause side effects.

The NavDx testing device, used for ctHPVDNA monitoring, has proven effective in detecting cancer recurrence in head and neck cancers. Although ctHPVDNA is a newer method, it hasn't been associated with significant side effects because it involves regular blood tests rather than more invasive procedures. Overall, using ctHPVDNA for monitoring after surgery appears to be a safe option for patients with HPV-related throat cancer.12345

Why are researchers excited about this trial?

Researchers are excited about using ctHPVDNA for active surveillance in throat cancer because it offers a cutting-edge way to monitor patients after surgery without the need for immediate radiation therapy. Unlike traditional methods that often involve radiation as a precautionary measure, this approach uses a blood test to detect circulating tumor DNA, allowing for a more personalized and less invasive monitoring process. This means fewer side effects and a focus on treating only those who show signs of recurrence, potentially improving quality of life while maintaining effective cancer control.

What evidence suggests that active surveillance with ctHPVDNA is effective for throat cancer?

Research has shown that using ctHPVDNA (a type of DNA found in the blood related to HPV) to monitor patients with HPV-related throat cancer holds promise. In one study, 94.5% of patients with a positive ctHPVDNA test experienced cancer recurrence, while those with negative tests rarely did. Another study found that all patients with no detectable ctHPVDNA after surgery remained cancer-free. In this trial, participants will undergo active surveillance with ctHPVDNA testing after surgery. This testing can help identify early signs of cancer returning, allowing for prompt treatment. Overall, using ctHPVDNA in regular check-ups could improve outcomes by detecting recurrences early.13678

Who Is on the Research Team?

BC

Bhishamjit Chera, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for adults with HPV-related throat cancer (oropharyngeal squamous cell carcinoma) who have had robotic surgery, show low or intermediate risk features, test negative for tumor HPV DNA after surgery, and have a limited smoking history. Tumors must be well-lateralized and meet specific size and lymph node criteria.

Inclusion Criteria

I am willing and able to follow all study procedures for the entire study period.
Provision of signed and dated informed consent form
≤10 pack-years of cigarette smoking or no cigarette smoking for ≥ 5 years regardless of pack years
See 15 more

Exclusion Criteria

I have not had radiation to my head or neck, except for small skin cancer treatments.
Current smoker or tobacco user
Prisoners or subjects involuntarily incarcerated or compulsorily detained for psychiatric or physical illness treatment
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Surgery

Participants undergo transoral robotic surgery (TORS) for HPV-associated oropharyngeal squamous cell carcinoma

1 week
1 visit (in-person)

Active Surveillance

Participants are observed without adjuvant radiation and followed with routine clinical surveillance and serial ctHPVDNA testing

2 years
Regular visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after the active surveillance period

3 years
Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Active Surveillance With ctHPVDNA (NavDx®)

Trial Overview

The study tests if it’s safe to skip radiation therapy after surgery in select patients by closely monitoring them using regular blood tests (ctHPVDNA/ NavDx®) to catch any early signs of cancer returning. All participants receive active surveillance instead of routine postoperative radiation.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Active Surveillance With ctHPVDNA After SurgeryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials
994
Recruited
7,408,000+

Citations

Plasma Circulating Tumor HPV DNA for the Surveillance of ...

After a median follow-up time of 23 months (range, 6.1-54.7 months), 15 patients (13%) developed disease recurrence. Eighty-seven patients had undetectable ...

Opinion: ctHPVDNA Testing Could Improve Surveillance in ...

Among the 58 patients with any positive ctHPVDNA test, 55 developed recurrence (94.5% PPV), while 8 out of 495 with all-negative test results ...

Surveillance - NavDx

Recurrence-free and overall survival were significantly worse for patients with any positive TTMV-HPV DNA test result identified during surveillance (p<0.0001)2 ...

Detectable Postoperative Circulating Tumor Human ...

Recurrence-free survival at 18 months was 83% (95% confidence interval, 47%-95%) for patients with detectable postop ctHPVDNA compared with 100% for patients ...

HPV ctDNA May Not Help Predict Recurrent Disease in ...

The utilization of TTMV-HPV DNA to select patients with human papillomavirus (HPV)–associated oropharyngeal carcinoma for active surveillance was not effective.

What we know and don't know about ctHPVDNA for ... - PMC

HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) has an overall favorable prognosis, yet a subset of patients will experience ...

Study Details | NCT04900623 | Risk-adapted Therapy in ...

This testing has shown promise in early detection of cancer recurrence in several solid tumor types (including colorectal, urothelial, and breast cancer).

Detection of Occult Recurrence Using Circulating Tumor ...

Circulating tumor DNA (ctDNA) has emerged as a diagnostic tool to detect the presence of cancer or quantify tumor burden among patients with cancer (22, 23).