Chemo + Surgery for Head and Neck Cancer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: George Washington University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The objective of this study is to assess the efficacy of induction chemotherapy followed by transoral surgical treatment and neck dissection, in definitive management of moderately advanced oropharyngeal squamous cell carcinoma. The surgical treatment will carry out Transoral Robotic Surgery (TORS) or Transoral Laser Microsurgery (TLM) for the primary tumor, and neck dissection for the management of cervical lymph nodes. The primary outcome measure will be disease specific survival (DSS). The secondary oncologic outcome measures will be locoregional control, relapse free survival, overall survival, and Quality of Life (QOL).

Research Team

Robert S Siegel, M.D.

Principal Investigator

George Washington University

Eligibility Criteria

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.

Inclusion Criteria

Protocol begins within 4 weeks of biopsy and within 3 weeks of the latest medical imaging

Men and women of child bearing potential must agree to use effective contraception while on the study, and women must have a negative pregnancy test, and not be lactating

Biopsy proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, vallecula, soft palate) and supraglottis

Exclusion Criteria

Patients with N3 disease (Stage IVB)

Patients having anatomy not allowing transoral access and exposure for surgery(Judged by the surgical PI at the time of biopsy under general anesthesia)

You have had any type of head and neck cancer before, except for non-serious skin cancers like basal or squamous cell carcinoma.

Treatment Details

Interventions

• Carboplatin (Alkylating agents)
• Cisplatinum (Alkylating agents)
• Docetaxel (Alkylating agents)
• Transoral Robotic Assisted Surgery (Procedure)

Trial Overview 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.

Participant Groups

Group I: Induction Therapy with 3 cycles Experimental Treatment 4 Interventions

Cisplatin 75mg/m2 IV and Taxotere 75mg/m2 every 3 weeks for 3 cycles (Induction Chemotherapy) followed by surgical treatment

Carboplatin is already approved in Canada for the following indications:

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

Jeffrey S. Akman

George Washington University

Chief Executive Officer since 2017

MD from Albert Einstein College of Medicine

Holly Miller

George Washington University

Chief Medical Officer since 2009

MD from Albert Einstein College of Medicine