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Alkylating agents

Reduced Radio-Chemotherapy for Oral Cancer

Phase 2

Recruiting

Led By Kathryn Hitchcock, MD, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

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

Must have

T0-3 ≤4cm, N0 to N2, M0 squamous cell carcinoma of the oropharynx by AJCC 8th Edition staging. If T0, adenopathy must be predominantly in Level 2

Tissue diagnosis of HPV and/or p16 positivity from the primary site or an associated lymph node

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial found that risk-adapted de-intensification of radiation therapy and chemotherapy based on HPV subtype, plasma circulating free HPV DNA (cfHPV DNA) level, and cfHPV DNA clearance rate is just as effective as more aggressive therapy in patients with favorable prognosis oropharyngeal squamous cell carcinoma (OPSCC).

Who is the study for?

This trial is for adults with HPV-positive oropharyngeal squamous cell carcinoma who have not smoked heavily in the past 10 years and are eligible for platinum chemotherapy. They must have good organ function, no severe illnesses that could interfere with treatment, and agree to use contraception if they can bear children.Check my eligibility

What is being tested?

The study tests whether less intense radiation therapy combined with chemotherapy based on individual risk factors like HPV subtype and cfHPV DNA levels can control cancer as effectively as more aggressive treatments in patients with a favorable prognosis of this type of oral cancer.See study design

What are the potential side effects?

Potential side effects include nausea, vomiting, kidney damage from Cisplatin; skin redness, irritation from Radiation therapy; fatigue; hearing loss; low blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

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

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My throat cancer is in an early to mid-stage and not spread far.

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My cancer is HPV or p16 positive.

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I can take care of myself and perform daily activities.

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I have smoked 10 or fewer pack-years or haven't smoked in 10 years.

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I am a candidate for platinum-based chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Local-Regional Control Rate

Secondary outcome measures

Disease-Free Survival

Distant Metastasis-Free Survival

Local Control Rate

+4 more

Side effects data

From 2013 Phase 3 trial • 397 Patients • NCT00004054

78%

Menopausal symptoms

60%

Urinary frequency

52%

Impotence

47%

Late RT Toxicity: Bladder: NOS

39%

Diarrhea NOS

27%

Late RT Toxicity: Bowel: NOS

26%

Fatigue

26%

Late RT Toxicity: Other GU: NOS

21%

Proctitis NOS

21%

Dysuria

14%

Libido decreased

14%

Dermatitis radiation NOS

12%

Late RT Toxicity: Other GI: NOS

12%

Late RT Toxicity: Other: NOS

12%

Hemoglobin decreased

12%

Alanine aminotransferase increased

Gynaecomastia

Urinary retention

Pain-other

Aspartate aminotransferase increased

Rectal bleeding

Constipation

Leukopenia NOS

Edema NOS

Hematuria present

Renal/GU-Other

Arthralgia

Blood creatinine increased

Dyspnea NOS

Dermatitis exfoliative NOS

Nausea

Hyperglycemia NOS

Depression NEC

Lymphopenia

Myalgia

Peripheral sensory neuropathy

Stomatitis

Platelet count decreased

Blood albumin decreased

Weight decreased

Anorexia

Hypocalcemia

Hyponatremia

Hematologic-Other

Neutropenia

Alopecia

100%

80%

60%

40%

20%

Study treatment Arm

Hormones and RT

Hormones and RT Plus Chemotherapy

Trial Design

1Treatment groups

Experimental Treatment

Group I: Chemo-radiotherapyExperimental Treatment2 Interventions

Participants will receive chemo-radiotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

2013

Completed Phase 3

~1940

Radiation therapy

2013

Completed Phase 3

~2850

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Naveris, Inc.Industry Sponsor

University of FloridaLead Sponsor

1,340 Previous Clinical Trials

715,455 Total Patients Enrolled

Kathryn Hitchcock, MD, PhDPrincipal InvestigatorUniversity of Florida

1 Previous Clinical Trials

650 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05268614 — Phase 2

Squamous Cell Carcinoma Research Study Groups: Chemo-radiotherapy

Squamous Cell Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT05268614 — Phase 2

Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05268614 — Phase 2

Frequently Asked Questions

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

Is there a high risk of negative side effects from Radiation therapy?

"While there is some evidence of safety, as this is a phase 2 trial, Power rates the safety of radiation therapy at a 2."

Answered by AI

Can adolescents participate in this clinical research?

"Those who wish to apply for this clinical trial must be between the ages of 18 to 99. Out of the 80 trials, 2740 are specifically for patients that are over 65 years old."

Answered by AI

Are new participants still being enrolled in this experiment?

"That is right, the clinical trial is currently underway. The original posting was on May 5th, 2022 and the most recent update was on July 14th, 2022. They are looking for 250 patients to enroll at 2 different sites."

Answered by AI