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Chemotherapy

Tailored Therapy for HPV-Related Oropharyngeal Cancer

Phase 2

Recruiting

Led By Jonathan D Schoenfeld, MD, MPH

Research Sponsored by Jonathan Schoenfeld, MD, MPH

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men who are sexually active with women of childbearing potential must agree to use any contraceptive method with a failure rate of less than 1% per year

Subject must have histologically or cytologically confirmed, stage I, II, or III (N3 disease excluded), HPV associated oropharyngeal (tongue base or tonsil) squamous cell carcinoma, as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition staging

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 5 years

Awards & highlights

Study Summary

This trial is testing if treatments can be tailored for people with HPV-related oropharynx cancers using both the stage of the tumor and the person's smoking status combined with an investigational HPV blood test.

Who is the study for?

Adults aged 22+ with HPV-related oropharyngeal cancer (stage I-III, excluding N3 disease) who have not had prior head and neck cancer treatments. Participants must be able to provide blood samples, have adequate organ function for chemotherapy, and use effective contraception if of childbearing potential.Check my eligibility

What is being tested?

The study is testing personalized treatment plans using clinical features and an investigational HPV blood test called NavDx®. It involves radiation therapy combined with chemotherapy drugs like Cisplatin or Carboplatin and Paclitaxel based on the individual's tumor DNA profile.See study design

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection; radiation therapy may cause skin irritation, sore throat; the NavDx® test itself has minimal risks associated with a standard blood draw.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man who will use highly effective birth control if having sex with women who can get pregnant.

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My cancer is HPV-related, in my throat (tongue or tonsil), and not the most advanced stage.

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My cancer is HPV positive, confirmed by a biopsy showing high p16 or DNA testing.

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My organs and bone marrow are healthy enough for chemotherapy with radiation.

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I can take care of myself but might not be able to do heavy physical work.

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I plan to treat my HPV+ throat cancer without surgery.

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My blood test shows HPV 16 before starting treatment.

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I am 22 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival 2 Years

Secondary outcome measures

Best Overall Response

Overall Survival at 2 Years

Rate of Distant Failure

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: LOW RISK RT (ALONE OR WITH SOC CHEMOExperimental Treatment3 Interventions

The research study procedures include: screening for eligibility, and study treatments including evaluations and follow-up visits NavDx HPV ctDNA Testing: Blood will be collected and shared with an outside lab for analysis (less than 10 mL of blood or about 2 teaspoons). The results of this test will determine what radiation dose received . The specimens will be de-identified. The specimens will be banked for future use. Radiation Therapy: Lower risk participants will receive a lower dose and treatment will only last 5-6 weeks. Chemotherapy: Chemotherapy and radiation therapy are both considered standard treatments for your type of cancer. The study doctor will decide whether or not chemotherapy with radiation and the type of chemotherapy. Bolus Cisplatin: Infused every 21 days for up to 2 or 3 doses. Weekly Cisplatin or Carboplatin with Paclitaxel: Infused weekly during radiation therapy

Group II: INTERMEDIATE RISK RT (ALONE OR WITH SOC CHEMOExperimental Treatment3 Interventions

The research study procedures include: screening for eligibility, and study treatments including evaluations and follow-up visits NavDx HPV ctDNA Testing: Blood will be collected and shared with an outside lab for analysis (less than 10 mL of blood or about 2 teaspoons). The results of this test will determine what dose of radiation received. The specimens will be de-identified. The specimens will be banked for future use. Radiation Therapy: Higher risk participants will receive standard radiation dose for up to 7-8 weeks Chemotherapy: Chemotherapy and radiation therapy are both considered standard treatments for your type of cancer. The study doctor will decide whether or not chemotherapy with radiation and the type of chemotherapy. Bolus Cisplatin: Infused every 21 days for up to 2 or 3 doses. Weekly Cisplatin or Carboplatin with Paclitaxel: Infused weekly during radiation therapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiotherapy

2017

Completed Phase 3

~2610

Chemotherapy drug

2020

N/A

~70

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jonathan Schoenfeld, MD, MPHLead Sponsor

NaverisUNKNOWN

2 Previous Clinical Trials

151 Total Patients Enrolled

Jonathan D Schoenfeld, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

66 Total Patients Enrolled

Media Library

Oropharyngeal Carcinoma Research Study Groups: INTERMEDIATE RISK RT (ALONE OR WITH SOC CHEMO, LOW RISK RT (ALONE OR WITH SOC CHEMO

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA recognize any chemotherapy medicines as safe and effective?

"Our team at Power gave Chemotherapy drug a score of 2 on the safety scale, due to it currently being in Phase 2 trials and having some evidence suggesting its security but no testimonies highlighting its effectiveness."

Answered by AI

How many subjects are enrolled to participate in this experiment?

"Correct. Clinicaltrials.gov data demonstrates that this medical trial, initially posted on July 2nd 2021, is still actively enrolling patients. 75 volunteers are needed from two different sites for the study to continue."

Answered by AI

Under what circumstances is a chemotherapeutic agent recommended?

"Chemotherapeutic agents are an effective tool for treating advanced endometrial cancer, melanoma and neoplasm metastasis."

Answered by AI

Is enrollment still open for the current clinical trial?

"According to the info on clinicaltrials.gov, this research is open for recruitment. It was initially launched on July 2nd of 2021 and was recently modified as of June 7th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study

Jonathan Schoenfeld, MD, MPH 2021. "Risk-adapted Therapy in HPV+ Oropharyngeal Cancer Using Circulating Tumor (ct)HPV DNA Profile - The ReACT Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04900623.