15 Participants Needed

Transoral Surgery + Reduced-Dose Radiation/Chemotherapy for Oropharyngeal Cancer

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Rutgers, The State University of New Jersey
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 is a non-randomized, open-label phase II clinical trial that studies the effect of reduced dose radiation therapy and chemotherapy after surgery in treating patients with human papillomavirus (HPV) caused throat cancer. Giving reduced dose radiation therapy and chemotherapy after surgery may improve quality of life compared with standard of care primary chemoradiation approach without compromising survival.

Who Is on the Research Team?

MI

Matin Imanguli, MD, DDS

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for adults with HPV-related throat cancer that can be surgically removed. Participants must have certain blood and organ function levels, not have had previous treatments for head and neck cancer, and women of childbearing age must test negative for pregnancy and use birth control. People with metastatic disease beyond the neck or serious health issues are excluded.

Inclusion Criteria

Platelets >= 100,000/ul
Must give informed consent
Negative pregnancy test, if applicable
See 11 more

Exclusion Criteria

I have not had treatment for my head and neck cancer, except for a biopsy.
I had another type of cancer but have been cancer-free for 3 years, or I have in situ carcinoma or non-melanoma skin cancer.
I am not pregnant and agree to use birth control during and 6 months after the study.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo transoral surgery to remove the tumor

1 week
1 visit (in-person)

Adjuvant Therapy

Participants receive reduced dose radiation therapy and chemotherapy based on risk group

5-6 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years
Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Cisplatin
  • External Beam Radiation Therapy
  • Transoral Surgery
Trial Overview The study tests if lower doses of radiation therapy and chemotherapy after surgery can maintain survival rates while improving quality of life in patients with HPV-caused throat cancer. It's a phase II trial where everyone gets the same treatment without being randomly assigned to different groups.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: GROUP III - High Risk Recurrence (transoral surgery, EBRT 60Gy, cisplatin 30 mg/m2)Experimental Treatment9 Interventions
Group II: GROUP II - Medium Risk Recurrence (transoral surgery, EBRT 50Gy)Experimental Treatment8 Interventions
Group III: GROUP I - Low Risk Recurrence (transoral surgery, clinical observation))Active Control7 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials
471
Recruited
81,700+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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