At a glance
ClinicalIndex Comparison Record- ✓Previously untreated, histologically proven squamous cell carcinoma arising in oral cavity, oropharynx, or supraglottic larynx, amenable to transoral approach
- ✓ECOG performance status 0-1
- ✓Measurable disease by RECIST 1.1
- ✓Age ≥18 years
- ✕T1N0 or T2N0 disease
- ✕Any metastatic disease
- ✕Not considered eligible for carboplatin, paclitaxel, or lapatinib
- ✕Current active hepatic or biliary disease (except Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multimodality Risk Adapted Therapy Including Carboplatin/Paclitaxel/Lapatinib as Induction for Squamous Cell Carcinoma of the Head and Neck Amenable to Transoral Surgical Approaches
In Brief
A Phase 2 clinical trial evaluating Carboplatin, Paclitaxel, and 5 other interventions for Head and Neck Cancer and Squamous Cell Carcinoma of the Head and Neck. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Weekly carboplatin given intravenously for 6 weeks during induction chemotherapy.
Weekly paclitaxel given intravenously prior to carboplatin infusion for 6 weeks during induction chemotherapy.
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.
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 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.
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.
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 resection by robotic or microscopic approach, which will be at the discretion of the treating surgeon.