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Alkylating agents
Cisplatin for Oropharyngeal Cancer
Phase 2
Waitlist Available
Led By Zachary S Zumsteg, MD
Research Sponsored by Zachary Zumsteg
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
p16 is strongly positive by immunohistochemistry or high-risk HPV is detected by in-situ hybridization
Have undergone or will undergo gross total resection of all known disease in the head and neck via transoral robotic surgery
Must not have
Prior radiation to the head and neck > 30 Gy
Prior active invasive malignancy within the prior 2 years, excluding specified types
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will study patients with a specific type of throat cancer who will undergo surgery to remove the visible tumor in the throat and lymph nodes.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Cisplatin may cause nausea, vomiting, kidney damage, hearing loss, nerve problems and an increased risk of infection due to lowered blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is linked to HPV or shows a strong p16 presence.
Select...
I will have or had surgery to remove all visible cancer in my head or neck.
Select...
My cancer is a specific type of throat cancer that is p16 positive.
Select...
My cancer has spread to at least one lymph node in my neck.
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I have had or will have surgery to remove lymph nodes in my neck.
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I am 18 years old or older.
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My cancer was advanced after surgery, showing one of several specific features.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have received radiation treatment to my head or neck area above 30 Gy.
Select...
I have not had any other cancer besides skin cancer in the last 2 years.
Select...
I have moderate to severe difficulty hearing.
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I am on immunosuppressants for my connective tissue disease.
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My cancer is at an advanced stage according to AJCC 8th edition.
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My cancer has spread to other parts of my body.
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It has been more than 56 days since my surgery to remove the cancer.
Select...
My cancer has come back after treatment.
Select...
My surgery couldn’t remove all of my tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
2-year progression-free (PFS)
Secondary study objectives
2-year Progression-Free Survival
Cause-Specific Survival
Distant Control
+10 moreSide effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Dyspnoea
1%
Cerebral infarction
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
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: Single ArmExperimental Treatment1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
Find a Location
Who is running the clinical trial?
Zachary ZumstegLead Sponsor
Zachary S Zumsteg, MDPrincipal InvestigatorCedars-Sinai Medical Center
1 Previous Clinical Trials
40 Total Patients Enrolled