Clinical trial NCT01612351
Conditions: Head and Neck Cancer Squamous Cell Carcinoma of the Head and Neck
Keywords: Head and neck cancer Squamous Cell Carcinoma Phase II Transoral Surgery Induction Chemotherapy Carboplatin Paclitaxel Lapatinib
Sponsor: UNC Lineberger Comprehensive Cancer Center
Start date: 2012-06-01; Completion date: 2025-05-19
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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.

Detailed description:
This is a single-arm non-randomized two-stage phase II trial in previously untreated patients with squamous cell carcinoma of the head and neck (SCCHN) arising in the oral cavity, oropharynx, or supraglottic larynx amenable to a transoral surgical approach. Treatment will consist of 3 parts: neoadjuvant induction with weekly carboplatin and paclitaxel in combination with daily lapatinib for 6 weeks (PART 1) prior to transoral surgery (PART 2). Post-operative treatment (PART 3) will vary depending on the risk category assigned to the patient following surgery as follows: no further treatment or treatment limited to involved field radiation (low risk), ipsilateral radiation concurrent with weekly chemotherapy ( medium risk); or cisplatin every 3 weeks and daily lapatinib concurrent with bilateral radiation (high risk).

Arms: arm 1: 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.
Interventions: intervention 1: Carboplatin intervention 2: Paclitaxel intervention 3: Lapatinib intervention 4: Cisplatin intervention 5: Cisplatin intervention 6: Ipsilateral Radiation intervention 7: Bilateral Radiation intervention 8: Transoral Surgery
Intervention descriptions: intervention 1: Weekly carboplatin given intravenously for 6 weeks during induction chemotherapy. intervention 2: Weekly paclitaxel given intravenously prior to carboplatin infusion for 6 weeks during induction chemotherapy. intervention 3: 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. intervention 4: 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. intervention 5: 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. intervention 6: 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. intervention 7: 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. intervention 8: Transoral resection by robotic or microscopic approach, which will be at the discretion of the treating surgeon.

Protocol documents: