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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
Must not have
Currently taking Disease Modifying Rheumatoid Drugs (DMRDs) or immunosuppressive medication
Prior radiotherapy or chemotherapy for this cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on medication for rheumatoid arthritis or to suppress my immune system.
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I have had radiotherapy or chemotherapy for my cancer.
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I had surgery to remove my oropharyngeal cancer.
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I have smoked the equivalent of 10 packs of cigarettes a year for over the last 10 years.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Local-Regional Control Rate
Secondary study objectives
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: NOS
12%
Late RT Toxicity: Other GI: NOS
12%
Hemoglobin decreased
12%
Alanine aminotransferase increased
9%
Gynaecomastia
8%
Urinary retention
7%
Pain-other
7%
Aspartate aminotransferase increased
6%
Rectal bleeding
6%
Constipation
6%
Leukopenia NOS
4%
Edema NOS
4%
Hematuria present
4%
Renal/GU-Other
3%
Arthralgia
3%
Blood creatinine increased
3%
Dyspnea NOS
3%
Dermatitis exfoliative NOS
2%
Depression NEC
2%
Nausea
2%
Hyperglycemia NOS
2%
Lymphopenia
2%
Myalgia
2%
Peripheral sensory neuropathy
1%
Platelet count decreased
1%
Hypocalcemia
1%
Hyponatremia
1%
Blood albumin decreased
1%
Stomatitis
1%
Weight decreased
1%
Anorexia
1%
Hematologic-Other
1%
Neutropenia
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Hormones and RT
Hormones and RT Plus Chemotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~3120
Radiation therapy
2013
Completed Phase 3
~2850

Find a Location

Who is running the clinical trial?

Naveris, Inc.Industry Sponsor
University of FloridaLead Sponsor
1,397 Previous Clinical Trials
766,810 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
~161 spots leftby Jun 2029
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