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

Recruiting in New Brunswick (>99 mi)

+2 other locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Metastatic disease, Serious systemic disorders, Age < 18, others

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

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

Compensation: Varies

Number of Visits: 1

15 Participants Needed

Trial Summary

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.

Research Team

Matin Imanguli, MD, DDS

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

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

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.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: GROUP III - High Risk Recurrence (transoral surgery, EBRT 60Gy, cisplatin 30 mg/m2) Experimental Treatment 9 Interventions

Patients whose tumor has a "positive margin", which means the tumor could not be removed with healthy tissue around it or tumor grows significantly outside the lymph node will undergo EBRT RT 60 Gy for 6 weeks and receive cisplatin intravenously (IV) weekly 30mg/m2 for 6 weeks in the absence of disease progression or unacceptable toxicity.

Group II: GROUP II - Medium Risk Recurrence (transoral surgery, EBRT 50Gy) Experimental Treatment 8 Interventions

Patients whose tumor was removed completely but has certain features that make it more likely to come back such as growth around the nerves or into the vessels, or has more than one lymph nodes involved, will undergo external body radiation therapy (EBRT) RT 50Gy for 5 weeks in the absence of disease progression or unacceptable toxicity.

Group III: GROUP I - Low Risk Recurrence (transoral surgery, clinical observation)) Active Control 7 Interventions

After standard of care transoral surgery, patients whose small tumor was removed completely and have only one lymph node involved will undergo clinical observation.

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+