Induction Chemotherapy Followed by Surgery for Locally Advanced Head and Neck Cancer

NCT02760667 | Unknown Phase 2

• 1 other identifier: GWU-MFA Head and Neck Protocol
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Head and Neck Cancer

Keywords

Oropharyngeal cancer; Laryngeal cancer

Outcome Measures

Primary Outcomes (1)

• Disease specific survival (DSS)

  this parameter is a number will tell the chances of staying free of the head and neck cancer after the study treatment.

  3 years

Secondary Outcomes (4)

• Relapse-free survival

  3 years

• Overall survival

  3 years

• EORTC QLQ-C30

  3 years

• EORTC QLQ-H&N35

  3 years

Study Arms (1)

Induction Therapy with 3 cycles

EXPERIMENTAL

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

Drug: Cisplatinum; Drug: Docetaxel; Drug: Carboplatin; Procedure: Transoral Robotic Assisted Surgery

Interventions

Cisplatinum DRUG

Cisplatin 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase

Also known as: Cisplatin

Induction Therapy with 3 cycles

Docetaxel DRUG

Docetaxel 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase

Also known as: Taxotere

Induction Therapy with 3 cycles

Carboplatin DRUG

Carboplatin AUC=5 every 3 weeks for a maximum of 3 cycles during the induction phase (if subject are unable to tolerate cisplatin)

Also known as: Paraplatin

Induction Therapy with 3 cycles

Transoral Robotic Assisted Surgery PROCEDURE

TORS will be performed for the patients who responded to the induction treatment (80% reduction)

Also known as: TORS

Induction Therapy with 3 cycles

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven squamous cell carcinoma of the oropharynx (tonsil, base of tongue, vallecula, soft palate) and supraglottis.
• Stages III (T1N1, T2N1, T3N0, T3N1) and stage IVA (T1N2, T2N2, T3N2, very select earlyT4) disease not previously treated with any method (Surgery, Radiation or Chemotherapy)
• No evidence of distant metastatic disease
• Fit for surgery and primary tumor assessed surgically resectable (by surgical PI) via transoral approach
• Age \> 18 years
• Karnofsky performance status \> 60%, or ECOG \< 2
• ANC \> 2,000, platelets \> 100,000 and calculated creatinine clearance \>50 cc/min
• Signed study specific consent form
• Protocol begins within 4 weeks of biopsy and within 3 weeks of the latest medical imaging.
• No other malignancies except cutaneous basal or squamous cell cancer within the last 5 years
• Patients must have measurable disease based on RECIST.
• 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.

You may not qualify if:

• Patients with advanced T4 cancer judged unresectable by transoral approach by surgical PI.
• Patients with N3 disease (Stage IVB).
• Patients with distant metastatic disease (Stage IVC).
• Patients with radiologically positive neck nodes with radiological evidence of extracapsular nodal tumor invasion.
• Patients having anatomy not allowing transoral access and exposure for surgery(Judged by the surgical PI at the time of biopsy under general anesthesia)
• Patients with prior head and neck cancer at any time (other than basal or squamous cell cancer of the skin)
• Coexistent second malignancy or history within 5 years of prior malignancy (other than basal or squamous cell cancer of the skin or curatively treated Stage I carcinoma of the cervix) renders the patient ineligible.
• Patients with peripheral neuropathy \>/= grade 1 will not be eligible for the study.
• Patients who have had prior Taxanes or Cisplatin
• Patients with concurrent infection are not eligible. All patients must be afebrile for at least 3 days prior to start of therapy unless fever is due to tumor.
• Patients with coexisting medical illness of a severity that might interfere with treatment or follow-up, or who do not have the ability to give informed consent.
• Patients who have received prior radiation therapy, surgery and chemotherapy for the tumor being treated.
• Patients must not be receiving any other investigational agent while on the study.

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University-Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms

Interventions

Cisplatin; Docetaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Robert S Siegel, M.D.

  George Washington University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: May 4, 2016
• Study Start: June 1, 2015
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)