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Combination Therapy
Personalized De-escalation Treatment for Oropharyngeal Cancer
Phase 2
Recruiting
Led By Michelle A Mierzwa
Research Sponsored by University of Michigan Rogel Cancer Center
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 2 years
Awards & highlights
Study Summary
This trial looks at ways to reduce treatment for early-stage oropharyngeal cancer, from surgery plus chemo/radiation to just chemo/radiation or just observation.
Who is the study for?
This trial is for adults over 18 with early-stage p16+ or HPV-positive squamous cell carcinoma of the oropharynx, who haven't had prior treatment for this cancer. They must have good bone marrow function and organ performance, no distant metastases, and be able to undergo PET/CT scans. Women and men must use birth control during the study.Check my eligibility
What is being tested?
The CuSToMIze trial at University of Michigan tests two less intense treatments for Stage I-II p16+ oropharyngeal cancer: (1) surgery followed by observation or adjusted radiation (+/- chemo), (2) personalized adaptive chemoradiation based on individual response.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with surgery, radiation therapy such as soreness, swelling, difficulty swallowing; chemotherapy-related issues like nausea, fatigue; plus any complications from anesthesia used during surgical procedures.
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
Loco-regional recurrence free survival (LR-RFS) rate
Secondary outcome measures
Acute toxicity
Disease specific survival (DSS) rate
Late toxicity
+3 moreSide effects data
From 2013 Phase 3 trial • 688 Patients • NCT0042425563%
Mucosal inflammation
52%
Nausea
48%
Rash
44%
Vomiting
42%
Diarrhoea
42%
Dry mouth
36%
Dysphagia
26%
Weight decreased
25%
Lymphopenia
24%
Leukopenia
22%
Anaemia
20%
Neutropenia
18%
Pyrexia
18%
Decreased appetite
17%
Constipation
17%
Asthenia
16%
Radiation skin injury
14%
Stomatitis
13%
Cough
13%
Oropharyngeal pain
13%
Blood creatinine increased
12%
Odynophagia
12%
Skin reaction
12%
Fatigue
12%
Hypokalaemia
9%
White blood cell count decreased
9%
Haemoglobin decreased
9%
Hyponatraemia
9%
Dysgeusia
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Dyspepsia
8%
Creatinine renal clearance decreased
7%
Dysphonia
7%
Pruritus
7%
Productive cough
7%
Oral pain
7%
Thrombocytopenia
6%
Lymphocyte count decreased
6%
Headache
6%
Neck pain
5%
Oral candidiasis
5%
Insomnia
4%
Radiation mucositis
4%
Musculoskeletal pain
3%
Ejection fraction decreased
2%
Pneumonia
2%
Dehydration
1%
Hepatic enzyme increased
1%
Oesophageal stenosis
1%
Pharyngeal fistula
1%
Epistaxis
1%
Hyperkalaemia
1%
Acute respiratory failure
1%
Mouth haemorrhage
1%
Wound infection
1%
Febrile neutropenia
1%
General physical health deterioration
1%
Hyperuricaemia
1%
Malnutrition
1%
Hypocalcaemia
1%
Feeding disorder
1%
Sepsis
1%
Lung abscess
1%
Oral infection
1%
Blood uric acid increased
1%
Dyspnoea
1%
Pneumonia aspiration
1%
Tracheostomy malfunction
1%
Cerebral ischaemia
1%
Renal failure
1%
Renal impairment
1%
Hyperbilirubinaemia
1%
Depression
1%
Death
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lapatinib 1500 mg
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Definitive CRTExperimental Treatment1 Intervention
Risk-adjusted definitive chemoradiation.
Group II: SurgeryActive Control4 Interventions
Surgery followed by risk-adjusted adjuvant treatment (observation, radiation, or chemoradiation).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemoradiation
2006
Completed Phase 3
~990
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,111 Total Patients Enrolled
Michelle A MierzwaPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received treatment for my cancer before.My diabetes is not well-controlled despite trying to manage it with fasting and medication adjustments.My kidney function, measured by creatinine levels, is normal or nearly normal.I am 18 years old or older.I agree to use effective birth control during the study.My cancer is at an advanced stage (Stage 3 or 4).My cancer is active, shows on PET scans, and is linked to HPV.My cancer is in the early stages (Stage I or II).My tumor can potentially be removed through surgery in my mouth, according to my surgeon.My scans show cancer spread to lymph nodes or surrounding areas.I am not pregnant and willing to use contraception if of childbearing potential.I have been cancer-free for at least 3 years, except for non-melanoma skin cancer.I have been mostly active and able to carry on all pre-disease activities without restriction recently.My recent blood test shows my bone marrow is working well.I had a PET/CT scan within the last 4 weeks.I can undergo PET/CT scans.I have liver problems causing jaundice or blood clotting issues.I've had radiation in the same area where my current cancer is located.
Research Study Groups:
This trial has the following groups:- Group 1: Surgery
- Group 2: Definitive CRT
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 challenges might a patient face when undergoing Definitive CRT?
"The safety of Definitive CRT scored a 2, as there is some documentation backing up its security but none that confirms its effectiveness."
Answered by AI
What is the enrolment capacity for this experiment?
"Confirmed. Per the information available on clinicaltrials.gov, this trial is currently enrolling participants; it was first listed on April 27th 2023 and last modified on May 30th of that same year. One centre requires 150 individuals to participate in this research endeavour."
Answered by AI
Are recruitment efforts underway for this research endeavor?
"According to the clinicaltrials.gov page, this study is currently enrolling patients and has been since April 27th of 2023. The trial was last modified on May 30th of that same year."
Answered by AI
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