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Alkylating agents

Cisplatin + Radiation for Head and Neck Cancer

Phase 2
Recruiting
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
Age must be ≥18 years
Patients must have pathologically proven diagnosis of head and neck squamous cell carcinoma (HNSCC) involving specific regions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will study the standard of care radiation therapy for squamous cell carcinoma of the head and neck, with the addition of either weekly or every 3-week cisplatin. The study will look at the relationship between the cisplatin toxicity and the level of reactive oxygen species generated by the drug.

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.Check my eligibility
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.See study design
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 am 18 years old or older.
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I have been diagnosed with squamous cell carcinoma in my head or neck.
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My cancer has not spread to distant parts of my body.
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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 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.
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I have not received chemotherapy for my advanced head or neck cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse event rate
Secondary outcome measures
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%
Cerebral infarction
1%
Dyspnoea
1%
Ischaemic stroke
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
~1940
XRT
1997
N/A
~40

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
Squamous Cell Carcinoma Research Study Groups: Every 3 Weeks Cisplatin + XRT, Weekly Cisplatin + XRT
Squamous Cell Carcinoma 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit on enrolment in this clinical trial?

"Indeed, the information accessed from clinicaltrials.gov supports that this research project is currently recruiting patient volunteers. This trial was initially published on April 11th 2017 and has recently been updated on November 17th 2021. A total of 80 participants are required for a single site evaluation."

Answered by AI

Is the enrollment period still open for participation in this trial?

"Affirmative. According to clinicaltrials.gov, this medical experiment was first listed on 4/11/2017 and is presently seeking 80 volunteers from a single location. The information was most recently updated on 11/17/2021."

Answered by AI

Have other experiments explored the effects of Cisplatin?

"Presently, 688 clinical trials are underway exploring the benefits of Cisplatin. Of these ongoing investigations, 274 are in Phase 3. Despite being based mainly in Shanghai, there exists 43211 sites conducting research on this treatment worldwide."

Answered by AI

Has the Food and Drug Administration sanctioned Cisplatin for therapeutic use?

"There is limited evidence that demonstrates Cisplatin's safety, hence it was assigned a rating of 2."

Answered by AI

In what ways does Cisplatin generally benefit patients?

"Often used to treat ovarian cancer, cisplatin can also be utilised for advanced testicular cancers that are unresponsive to conventional treatments as well as various other medical conditions."

Answered by AI
~7 spots leftby Nov 2024