Multimodality Risk Adapted Tx Including Induction Chemo for SCCHN Amenable to Transoral Surgery

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT01612351
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Weekly carboplatin given intravenously for 6 weeks during induction chemotherapy.
  • Paclitaxel — DRUG
    Weekly paclitaxel given intravenously prior to carboplatin infusion for 6 weeks during induction chemotherapy.
  • Lapatinib — DRUG
    Lapatinib (1000mg) taken by mouth once a day either one hour before or one hour after a meal for 6 weeks during induction chemotherapy. Participants deemed high risk following transoral surgery will additionally take lapatinib daily concurrently with their chemoradiation therapy.
  • Cisplatin — DRUG
    Weekly cisplatin given intravenously for 6 weeks concurrent with ipsilateral radiation. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.
  • Cisplatin — DRUG
    Cisplatin given once every 3 week cycle intravenously for 5-7 weeks concurrent with bilateral radiation and daily lapatinib. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.
  • Ipsilateral Radiation — RADIATION
    After transoral surgery, subjects deemed medium risk will receive ipsilateral radiation as per standard of care 5 days/week for 6 weeks concurrent with weekly cisplatin.
  • Bilateral Radiation — RADIATION
    After transoral surgery, subjects deemed high risk will receive bilateral radiation as per standard of care 5 days/week for 5-7 weeks concurrent with cisplatin every 3 weeks and daily lapatinib.
  • Transoral Surgery — PROCEDURE
    Transoral resection by robotic or microscopic approach, which will be at the discretion of the treating surgeon.

Study Details

The purpose of this study is to see if a three method risk adapted design using induction chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make treatment of squamous cell carcinoma of the head and neck (SCCHN) better.

Key Dates

Start date
Jun 30, 2012
Status verified
Feb 2026
Primary completion
Nov 30, 2016
Completion
May 19, 2025

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Non-Randomized Single-Arm
    All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 11 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599-

Find similar trials in Chapel Hill, NC

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
The University of North Carolina at Chapel Hill· Chapel Hill, NC

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