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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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 • NCT0100568051%
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%
Cerebral infarction
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV-positive with uncontrolled HIV.I recently underwent chemotherapy or radiotherapy.I agree to use effective birth control methods.I had head or neck cancer before and can handle the full dose of radiation and chemotherapy.I have not received chemotherapy for my advanced head or neck cancer.My cancer has spread from its original location.My disease can be measured according to my treatment group's rules.I have not had certain types of cancer before.I do not have any uncontrolled illnesses.I agree to use birth control during the study.My cancer is considered high-risk based on its characteristics.I am 18 years old or older.My cancer has not spread to distant parts of my body.I have been diagnosed with squamous cell carcinoma in my head or neck.I can take care of myself and am up and about more than half of my waking hours.My organ and bone marrow functions are normal.I have severe hearing loss.
Research Study Groups:
This trial has the following groups:- Group 1: Every 3 Weeks Cisplatin + XRT
- Group 2: Weekly Cisplatin + XRT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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