Phase II study of stereotactic radiosurgery for the treatment of patients with oligoprogression on erlotinib.

Introduction: Retrospective studies have evaluated the approach of stereotactic radiotherapy (SRT) to address oligoprogression in patients with EGFR mutant NSCLC on TKI therapy, it has never been prospectively studied.

Materials And Methods: We treated 25 patients with EGFR mutant NSCLC on erlotinib who had 3 or fewer sites of extra-cranial progression with SRT to progressing sites, followed by re-initiation of erlotinib.

Results: Median PFS from the initiation of SRT was 6 months (95% CI 2.

Phase 2 trial of neoadjuvant chemotherapy and transoral endoscopic surgery with risk-adapted adjuvant therapy for squamous cell carcinoma of the head and neck.

Background: The objective of this study was to demonstrate the feasibility and efficacy of induction chemotherapy, surgery, and pathology-guided adjuvant therapy to treat transorally resectable squamous head and neck cancer.

Methods: Patients had squamous head and neck cancer that was resectable by the transoral route and advanced-stage disease (American Joint Committee on Cancer stage III-IV, T3-T4 tumors, and/or positive lymph nodes). They received treatment with weekly carboplatin at an area under the curve of 2, plus paclitaxel 135 mg/m , and daily lapatinib 1000mg for 6 weeks followed by surgical resection.

Two-stage design for phase II oncology trials with relaxed futility stopping.

Many oncology phase II trials are single arm studies designed to screen novel treatments based on efficacy outcome. Efficacy is often assessed as an ordinal variable based on a level of response of solid tumors with four categories: complete response, partial response, stable disease and progression. We describe a two-stage design for a single-arm phase II trial where the primary objective is to test the rate of tumor response defined as complete plus partial response, and the secondary objective is to estimate the rate of disease control defined as tumor response plus stable disease.