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

• Status: Active, not recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: George Washington University
• Treatments: Carboplatin; Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.