Cisplatin for Oropharyngeal Cancer

Recruiting at 3 trial locations

Overseen By Clinical Trial Navigator

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Zachary Zumsteg

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a single institution phase II study that will enroll patients with T0-3N0-2 p16-positive oropharyngeal squamous cell carcinoma (OSCC) undergoing resection of all gross visible disease at the primary site and in the lymph nodes.

Research Team

Zachary S. Zumsteg

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

This trial is for individuals with p16-positive oropharyngeal squamous cell carcinoma (OSCC) who have had surgery to remove all visible cancer from the throat and lymph nodes. Details on eligibility criteria are not fully provided.

Inclusion Criteria

I have had or will have surgery to remove lymph nodes in my neck.

I will have or had surgery to remove all visible cancer in my head or neck.

My cancer is linked to HPV or shows a strong p16 presence.

Exclusion Criteria

Pregnant or breast-feeding women

My cancer has spread to other parts of my body.

It has been more than 56 days since my surgery to remove the cancer.

Treatment Details

Interventions

• Cisplatin (Alkylating agents)

Trial Overview The study is testing how well Cisplatin, a chemotherapy drug, works in treating HPV-associated throat cancer after surgery. It's a phase II trial at one medical institution.

Participant Groups

Group I: Single Arm Experimental Treatment 1 Intervention

Low risk pathology with post-op HPV DNA (-): cisplatin-based chemoradiation with 30 Gy in 15 fractions and 3 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, and 15 of radiation. Low risk pathology with post-op HPV DNA (+): cisplatin-based chemoradiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation. High risk pathology with post-op HPV DNA (-), excluding patients with both 5 LN+ and ENE+ or pre-op HPV DNA≤12 copies/mL: cisplatin-based radiation with 40 Gy in 20 fractions and 4 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, and 22 of radiation. High risk pathology with post-op HPV DNA (+) OR pre-op HPV DNA≤12 copies/mL OR both 5 or more LN+ and ENE+: cisplatin-based radiation with 50 Gy in 25 fractions with 5 cycles of weekly cisplatin 40mg/m2 IV on Days 1, 8, 15, 22, and 29 of radiation.

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

Zachary Zumsteg

Lead Sponsor

Trials

1

Recruited

50+