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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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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

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 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

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

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Dyspnoea

Cerebral infarction

Ischaemic stroke

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

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

0 / 16Eligibility criteria met