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Alkylating agents
Chemo + Surgery for Head and Neck Cancer
Phase 2
Waitlist Available
Research Sponsored by George Washington University
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 3 years
Awards & highlights
Study Summary
This trial will assess the efficacy of chemo and surgery for treating oropharyngeal cancer, with the aim of increasing survival and QOL.
Who is the study for?
This trial is for adults over 18 with certain stages of oropharyngeal squamous cell carcinoma, who haven't had previous cancer treatments. Participants must be fit for surgery, have no distant metastases, and agree to use contraception. Exclusions include severe concurrent illness, prior head and neck cancers (except some skin cancers), and those with specific types of advanced cancer.Check my eligibility
What is being tested?
The study tests if induction chemotherapy followed by transoral robotic surgery (TORS) or laser microsurgery (TLM) improves survival in head and neck cancer patients. It measures disease-specific survival as the main outcome, along with other factors like overall survival and quality of life.See study design
What are the potential side effects?
Potential side effects from the chemotherapy drugs Cisplatinum, Docetaxel, Carboplatin may include nausea, vomiting, hair loss, fatigue, kidney issues and nerve damage. Surgical risks involve bleeding, infection and complications related to anesthesia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease specific survival (DSS)
Secondary outcome measures
EORTC QLQ-C30
EORTC QLQ-H&N35
Overall survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Induction Therapy with 3 cyclesExperimental Treatment4 Interventions
Cisplatin 75mg/m2 IV and Taxotere 75mg/m2 every 3 weeks for 3 cycles (Induction Chemotherapy) followed by surgical treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Carboplatin
FDA approved
Find a Location
Who is running the clinical trial?
George Washington UniversityLead Sponsor
243 Previous Clinical Trials
453,227 Total Patients Enrolled
Robert S Siegel, M.D.Study ChairGeorge Washington University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had any type of head and neck cancer before, except for non-serious skin cancers like basal or squamous cell carcinoma.You have previously received treatment with Taxanes or Cisplatin.You have nerve damage in your extremities that is at least grade 1 or higher.If you have had another type of cancer within the past 5 years, except for certain types of skin cancer or early-stage cervical cancer, you cannot participate.
Research Study Groups:
This trial has the following groups:- Group 1: Induction Therapy with 3 cycles
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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