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Alkylating agents

Chemo-Emboli zation for Head and Neck Cancer

Phase 2
Waitlist Available
Led By Jesse Jones, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with squamous cell carcinoma of the Head and Neck
Platinum-ineligible as determined by presence of CTS grade I nephropathy, neuropathy or otopathy, and/or ECOG 2+ performance status.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will compare different cancer treatments to see if one is better than the others at extending life and/or reducing tumor growth, while also being tolerable for patients.

Who is the study for?
This trial is for adults over 18 with squamous cell carcinoma of the head and neck who can't use cisplatin due to certain health issues like kidney, nerve, or ear problems. They must be able to have chemo-embolization, follow study rules, and plan standard cancer treatments. Pregnant women and those unfit for the procedure are excluded.Check my eligibility
What is being tested?
The study tests if adding chemo-embolization to usual cancer care (radiation plus chemotherapy/immunotherapy) helps patients live longer without their cancer getting worse compared to just standard care in those who cannot tolerate cisplatin.See study design
What are the potential side effects?
Chemo-embolization may cause side effects such as pain at the injection site, fever, nausea, vomiting, fatigue. There's also a risk of more serious complications like liver damage or abnormal heart rhythms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with squamous cell carcinoma in my head or neck.
Select...
I cannot receive platinum-based chemotherapy due to kidney, nerve, or ear problems, or because my physical health status is limited.
Select...
I am fit for chemo-embolization treatment.

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
Evaluate progression free survival
Secondary outcome measures
Evaluate oropharyngeal bleeding
Evaluate overall 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%
Ischaemic stroke
1%
Dyspnoea
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)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chemo-embolizationExperimental Treatment1 Intervention
Intra-arterial Cisplatin suspension 150-300 mg is infused into the tumor pedicle(s)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,277,981 Total Patients Enrolled
Jesse Jones, MDPrincipal InvestigatorThe University of Alabama at Birmingham

Media Library

Cisplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04595981 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Chemo-embolization
Squamous Cell Carcinoma Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT04595981 — Phase 2
Cisplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04595981 — Phase 2

Frequently Asked Questions

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

Are we still looking for test subjects for this experiment?

"The listing on clinicaltrials.gov says that this trial is currently looking for subjects. The posting went up on 3/10/2021 and the most recent edit was on 5/26/2022. There is space for 48 people at 1 location."

Answered by AI

Has the Food and Drug Administration given their seal of approval to Cisplatin?

"Cisplatin has some clinical data supporting its safety, but none yet for efficacy. Therefore, it was given a score of 2."

Answered by AI

How many people are chosen to participate in this test?

"The listed clinical trial on clinicaltrials.gov is recruiting patients. The posting dates are from March 10th, 2021 to May 26th, 2022 and the study is looking for a total of 48 participants at 1 location."

Answered by AI

What therapeutic purposes does Cisplatin typically serve?

"Cisplatin is an effective treatment option for patients with advanced ovarian cancer, advanced testicular cancer, and who have become refractory to standard therapies."

Answered by AI

Could you please share what other researchers have uncovered about Cisplatin?

"As of the current moment, there are 714 Cisplatin trials underway. Out of those, 284 have progressed to Phase 3 clinical trials. Most of these studies originated in Shanghai but they are being conducted in 43258 different locations worldwide."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Chemo-embolization for Head and Neck Cancer
Jesse G. A. Jones, MD 2021. "Chemo-embolization for Head and Neck Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04595981.
~9 spots leftby Jan 2025
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