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Alkylating agents
Cisplatin for Oropharyngeal Cancer
Beverly Hills, CA
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.
See full description
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.Check my eligibility
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.See study design
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.
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I will have or had surgery to remove all visible cancer in my head or neck.
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My cancer is a specific type of throat cancer that is p16 positive.
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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.
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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.
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I have not had any other cancer besides skin cancer in the last 2 years.
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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.
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My cancer has come back after treatment.
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My surgery couldn’t remove all of my tumor.
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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 2023 Phase 3 trial • 457 Patients • NCT0400571685%
Anaemia
79%
Alopecia
66%
Neutropenia
56%
White blood cell count decreased
48%
Thrombocytopenia
44%
Nausea
39%
Decreased appetite
37%
Constipation
33%
Leukopenia
30%
Alanine aminotransferase increased
25%
Vomiting
24%
Hypoalbuminaemia
24%
Hyponatraemia
22%
Aspartate aminotransferase increased
22%
Neutrophil count decreased
17%
Hypokalaemia
17%
Insomnia
16%
Diarrhoea
16%
Cough
15%
Rash
15%
Arthralgia
14%
Platelet count decreased
14%
Hyperuricaemia
13%
Malaise
13%
Pyrexia
12%
Hypothyroidism
12%
Fatigue
12%
Gamma-glutamyltransferase increased
12%
Hyperglycaemia
11%
Blood creatine phosphokinase increased
11%
Lymphocyte count decreased
11%
Weight decreased
11%
Pain in extremity
11%
Dizziness
11%
Dyspnoea
10%
Hypertriglyceridaemia
10%
Headache
10%
Haemoptysis
10%
Productive cough
9%
Hypertension
9%
Hypochloraemia
8%
Non-cardiac chest pain
8%
Blood creatinine increased
8%
Weight increased
8%
Hypocalcaemia
7%
Hyperthyroidism
7%
Abdominal pain upper
7%
Asthenia
7%
Upper respiratory tract infection
7%
Blood bilirubin increased
7%
Back pain
7%
Pruritus
6%
Abdominal distension
6%
Chest discomfort
6%
Blood alkaline phosphatase increased
6%
Blood lactate dehydrogenase increased
5%
Toothache
5%
Oedema peripheral
5%
Blood creatine phosphokinase MB increased
5%
Hypercholesterolaemia
5%
Hypomagnesaemia
5%
Hiccups
4%
Sinus tachycardia
4%
Gingival pain
4%
Face oedema
4%
Infusion related reaction
4%
Hypophosphataemia
4%
Cancer pain
4%
Tumour pain
4%
Hypoaesthesia
3%
Abdominal pain
3%
Mouth ulceration
3%
Bilirubin conjugated increased
3%
Pneumonitis
2%
Pneumonia
2%
Dysphagia
2%
Fibrin D dimer increased
1%
Febrile neutropenia
1%
COVID-19 pneumonia
1%
Depressed level of consciousness
1%
Death
1%
Diabetes mellitus
1%
Immune-mediated myocarditis
1%
Type 1 diabetes mellitus
1%
Ileus
1%
Intestinal obstruction
1%
Immune-mediated hepatitis
1%
Neuropathy peripheral
1%
Oral pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Tislelizumab + Chemotherapy
Arm B: Placebo + 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: 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
~3040
Find a Location
Closest Location:Cedars Sinai Medical Center· Los Angeles, CA· 1976 miles
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