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Carboplatin for Squamous Cell Carcinoma
Phase 2
Waitlist Available
Led By Quon Harry, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit
Awards & highlights
Study Summary
This study is evaluating whether a smaller dose of radiation can be used to treat people with squamous cell carcinoma of the oropharynx.
Eligible Conditions
- Squamous Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6-8 weeks, 1 year, 2 years, 3 years, 4-5 year visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events and Their Cause
Percentage of Patients Free of Grade 3+ Late Toxicity
Percentage of Patients With Locoregional Tumor Control
+3 moreSide effects data
From 2022 Phase 3 trial • 1301 Patients • NCT0303810060%
ALOPECIA
51%
NAUSEA
45%
ARTHRALGIA
44%
ANAEMIA
38%
FATIGUE
35%
HYPERTENSION
35%
CONSTIPATION
35%
DIARRHOEA
30%
NEUTROPENIA
28%
PERIPHERAL SENSORY NEUROPATHY
28%
ABDOMINAL PAIN
28%
NEUTROPHIL COUNT DECREASED
24%
NEUROPATHY PERIPHERAL
24%
RASH
23%
HEADACHE
23%
VOMITING
22%
WHITE BLOOD CELL COUNT DECREASED
22%
MYALGIA
21%
PROTEINURIA
21%
EPISTAXIS
21%
PLATELET COUNT DECREASED
21%
THROMBOCYTOPENIA
19%
DECREASED APPETITE
18%
HYPOTHYROIDISM
17%
URINARY TRACT INFECTION
16%
COUGH
16%
PYREXIA
15%
STOMATITIS
14%
HYPOMAGNESAEMIA
14%
ASPARTATE AMINOTRANSFERASE INCREASED
14%
BACK PAIN
14%
INSOMNIA
14%
ALANINE AMINOTRANSFERASE INCREASED
14%
DYSPNOEA
14%
PRURITUS
13%
WEIGHT DECREASED
13%
PAIN IN EXTREMITY
12%
DIZZINESS
12%
INFUSION RELATED REACTION
12%
ASTHENIA
11%
LEUKOPENIA
11%
HYPOKALAEMIA
10%
UPPER RESPIRATORY TRACT INFECTION
9%
DYSGEUSIA
8%
ABDOMINAL PAIN UPPER
8%
FEBRILE NEUTROPENIA
8%
HYPOAESTHESIA
8%
WEIGHT INCREASED
8%
HYPERTHYROIDISM
7%
BONE PAIN
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPHONIA
7%
MUCOSAL INFLAMMATION
7%
MUSCULAR WEAKNESS
7%
HYPONATRAEMIA
7%
PARAESTHESIA
7%
OROPHARYNGEAL PAIN
7%
DYSPEPSIA
7%
RASH MACULO-PAPULAR
7%
HYPERGLYCAEMIA
6%
BLOOD ALKALINE PHOSPHATASE INCREASED
6%
OEDEMA PERIPHERAL
6%
NASOPHARYNGITIS
6%
ABDOMINAL DISTENSION
6%
ANXIETY
5%
PAIN
5%
DEPRESSION
5%
DRY MOUTH
5%
MALAISE
5%
NASAL CONGESTION
5%
VISION BLURRED
5%
DRY SKIN
5%
URTICARIA
5%
HOT FLUSH
5%
NECK PAIN
4%
GASTROOESOPHAGEAL REFLUX DISEASE
2%
ILEUS
2%
PNEUMONIA
2%
PULMONARY EMBOLISM
2%
COLITIS
2%
SMALL INTESTINAL OBSTRUCTION
1%
PERITONITIS
1%
LIVER INJURY
1%
INTESTINAL OBSTRUCTION
1%
UROSEPSIS
1%
DEHYDRATION
1%
TRANSIENT ISCHAEMIC ATTACK
1%
PNEUMONITIS
1%
ABDOMINAL ABSCESS
1%
INFECTED LYMPHOCELE
1%
PYELONEPHRITIS
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
Placebo With Paclitaxel, Carboplatin and Bevacizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose de-escalating radiation therapy with chemotherapyExperimental Treatment3 Interventions
This protocol combines selective radiation therapy dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks) in patients with HPV-associated cancers of the oropharynx
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Carboplatin
FDA approved
IMRT
2003
Completed Phase 3
~1570
Find a Location
Who is running the clinical trial?
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,860 Total Patients Enrolled
Quon Harry, M.D.Principal InvestigatorJohns Hopkins University
Arlene Forastiere, M.D.Principal InvestigatorJohns Hopkins University
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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