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Alkylating agents

Cisplatin + Radiation for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Susanne Arnold, MD
Research Sponsored by Susanne Arnold
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a history of prior head and neck malignancy must be able to tolerate full dose radiation and chemotherapy
No prior chemotherapy for the current locally advanced SCCHN is allowed
Must not have
HIV-positive patients with uncontrolled HIV
Patients who had recent chemotherapy or radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial involves treating patients with advanced head and neck cancer using a combination of radiation and the chemotherapy drug cisplatin. The goal is to see how effective this treatment is and how it affects patients. Different dosing schedules of cisplatin during radiation are being explored for efficacy and toxicity.

Who is the study for?
Adults with certain types of head and neck cancer (SCCHN) who haven't had chemotherapy for their current advanced cancer can join. They must be able to tolerate full treatment, have no distant metastases, and agree to use effective birth control. Those with significant hearing loss or other recent cancers (except specific cases in remission), uncontrolled illnesses, or pregnant/nursing women cannot participate.
What is being tested?
The trial is testing the effectiveness of standard radiation therapy combined with cisplatin given either weekly or every three weeks on SCCHN. It also examines how the drug's toxicity relates to oxidative stress markers produced during treatment.
What are the potential side effects?
Cisplatin may cause side effects like kidney damage, hearing loss, nausea and vomiting, blood cell count changes increasing infection risk, nerve damage leading to numbness or tingling sensations. Radiation therapy might result in skin irritation at the treated site, fatigue, dry mouth or throat discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had head or neck cancer before and can handle the full dose of radiation and chemotherapy.
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I have not received chemotherapy for my advanced head or neck cancer.
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I am 18 years old or older.
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My cancer has not spread to distant parts of my body.
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I have been diagnosed with squamous cell carcinoma in my head or neck.
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I can take care of myself and am up and about more than half of my waking hours.
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My organ and bone marrow functions are normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am HIV-positive with uncontrolled HIV.
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I recently underwent chemotherapy or radiotherapy.
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I have not had certain types of cancer before.
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I do not have any uncontrolled illnesses.
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I have severe hearing loss.
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My cancer has spread from its original location.

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
Adverse event rate
Secondary study objectives
Local control rates
Survival

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
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

2Treatment groups
Experimental Treatment
Group I: Weekly Cisplatin + XRTExperimental Treatment2 Interventions
Weekly Cisplatin + XRT
Group II: Every 3 Weeks Cisplatin + XRTExperimental Treatment2 Interventions
Every 3 Weeks Cisplatin + XRT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~3120
XRT
1997
N/A
~40

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cisplatin, a common treatment for Squamous Cell Carcinoma (SCC), exerts its effects by causing DNA damage and generating reactive oxygen species (ROS). The DNA damage inhibits cancer cell replication, while ROS further damages cellular components, leading to cell death. This dual mechanism is crucial for effectively targeting and killing SCC cells, thereby improving treatment outcomes for patients.
Alleviation of cytotoxic therapy-induced normal tissue damage.Comparison of Carboplatin With 5-Fluorouracil vs. Cisplatin as Concomitant Chemoradiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma.Emerging therapeutic options for platinum-sensitive ovarian cancer patients.

Find a Location

Who is running the clinical trial?

Susanne ArnoldLead Sponsor
10 Previous Clinical Trials
1,252 Total Patients Enrolled
Susanne Arnold, MDPrincipal Investigator - University of Kentucky
University of Kentucky Albert B. Chandler Hospital
University Of Kentucky College Of Medicine (Medical School)
University Of Ky Hosp-Chandler Mc (Residency)
6 Previous Clinical Trials
122 Total Patients Enrolled

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02994069 — Phase 2
Head and Neck Cancers Research Study Groups: Every 3 Weeks Cisplatin + XRT, Weekly Cisplatin + XRT
Head and Neck Cancers Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT02994069 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02994069 — Phase 2
~9 spots leftby Dec 2025