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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
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease specific survival (DSS)
Secondary study objectives
EORTC QLQ-C30
EORTC QLQ-H&N35
Overall survival
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
252 Previous Clinical Trials
461,130 Total Patients Enrolled
Robert S Siegel, M.D.Study ChairGeorge Washington University

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02760667 — Phase 2
Head and Neck Cancers Research Study Groups: Induction Therapy with 3 cycles
Head and Neck Cancers Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT02760667 — Phase 2
Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02760667 — Phase 2
~2 spots leftby Nov 2025
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