Cisplatin for Squamous Cell Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Squamous Cell Carcinoma+1 MoreCisplatin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Head and Neck Cancer
  • Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 2 years

2 years
Local control rates
Survival
90 days
Adverse event rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Gemcitabine Plus Cisplatin (GC)
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%Thrombocytopenia
10%Aspartate aminotransferase increased
9%Blood sodium decreased
8%Hypokalaemia
7%Pyrexia
7%Insomnia
6%Cough
6%Hyponatraemia
6%Lymphopenia
6%Blood creatinine increased
6%Diarrhoea
6%Dyspepsia
6%Red blood cell count decreased
4%Dizziness
2%Bone marrow failure
1%Dyspnoea
1%Pulmonary embolism
1%Superior vena cava syndrome
1%Cerebral infarction
1%Embolism venous
1%Ischaemic stroke
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01005680) in the Gemcitabine Plus Cisplatin (GC) ARM group. Side effects include: Neutropenia with 51%, Leukopenia with 47%, Nausea with 46%, Vomiting with 43%, Anaemia with 35%.

Trial Design

2 Treatment Groups

Every 3 Weeks Cisplatin + XRT
1 of 2
Weekly Cisplatin + XRT
1 of 2

Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Cisplatin · No Placebo Group · Phase 2

Every 3 Weeks Cisplatin + XRTExperimental Group · 2 Interventions: XRT, Cisplatin · Intervention Types: Radiation, Drug
Weekly Cisplatin + XRTExperimental Group · 2 Interventions: XRT, Cisplatin · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XRT
1997
N/A
~40
Cisplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

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

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a history of prior head and neck malignancy, but are not currently undergoing radiation therapy or chemotherapy for the current head and neck cancer