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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 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

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 more

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
243 Previous Clinical Trials
453,754 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the biggest number of people who have been involved in this research project?

"This particular clinical trial is no longer recruiting patients. The listing for the trial was first posted on June 1st, 2015 and edited for the last time on November 14th, 2022. However, there are 499 other trials involving head and neck cancer that are still recruiting patients as well as 1399 trials concerning Induction Therapy with 3 cycles."

Answered by AI

Are patients still being enrolled in this program?

"This clinical trial is not looking for participants at this time. The study was posted on 6/1/2015 and last updated on 11/14/2022. There are 499 other trials actively admitting patients with head and neck cancer and 1399 trials for Induction Therapy with 3 cycles that are recruiting patients right now."

Answered by AI

What is the standard application of Induction Therapy with 3 cycles?

"Induction Therapy, which consists of 3 cycles, can be used to treat patients with melanoma, head cancer, and soft tissue sarcoma (STS)."

Answered by AI

Is it permissible to give three rounds of Induction Therapy according to FDA guidelines?

"Induction Therapy with 3 cycles was given a score of 2. This is due to the lack of efficacy data, but there are clinical trials that support its safety."

Answered by AI

Is this the first clinical trial to use Induction Therapy with 3 cycles?

"Currently, 1399 different clinical trials are investigating the effects of Induction Therapy with 3 cycles. Most of these 477 Phase 3 studies originate from Shanghai, but there are 81423 total locations where these investigations are taking place."

Answered by AI
~2 spots leftby Apr 2025