Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy (PARTIST) for Locally Advanced, Non-small Cell Lung Cancer With Genomic Driver Mutations
Hypotheses: Short-term - Targeted therapy with erlotinib or crizotinib plus PART (Personalized Adaptive Radiation Therapy) will be safe and will yield favorable outcomes in patients with stage III, EGFR (Epidermal Growth Factor Receptor) + or ALK (Anaplastic Lymphoma Kinase) + NSCLC (Non-Small Cell Lung Cancer). Long-term - In patients with stage III NSCLC harboring driver mutations, treatment with relevant targeted agents plus PART will improve both local-regional and systemic tumor control resulting in improved survival relative to standard chemoradiotherapy.
Checked against the public recordLast updated Jun 24, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Early Phase 1
- Sponsor
- University of Michigan Rogel Cancer Center
- Interventions being studied
- Radiation: PET-Adaptive RT; Drug: Erlotinib; Drug: Crizotinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: * Patients with FDG-avid (radioactive glucose) and pathologically proven stage IIA-IIB or IIIA-IIIB non-small cell lung cancer (according to AJCC \[American Joint Committee on Cancer\] staging, 7th edition). * Patients with tumors that harbor either EGFR sensitizing mutations or ALK rearrangement. * Patients must be considered unresectable or medically inoperable; patients who decline surgery are also eligible. * Patients must be 18 years of age or older. * Patients with ECOG (Eastern Cooperative Oncology Group) performance status of 0-2. * Patients must have adequate organ function. * Patients must be able to take oral medications. * Women with reproductive capability must be willing to use effective contraception. * Patients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelines. * Patients must be willing to comply with study procedures. Exclusion Criteria: * Patients with tumors that have a component of small cell carcinoma. * Patients wtih stage I, II, or IV disease, including malignant pleural or pericardial effusion. * Prior radiotherapy to the thorax such that composite radiation would significantly over-dose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints. * Patients who cannot tolerate thoracic radiotherapy or targeted therapy. * Patients wtih a prior diagnosis of interstitial lung disease or pulmonary fibrosis. * Patients who cannot take oral medication, require intravenous alimentation, had prior surgical procedures affecting gastrointestinal absorption, or have active peptic ulcer disease. * Hypersensitivity to erlotinib, crizotinib, or to any of the excipients. * Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. * Prisoners are excluded from this study.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 24, 2016. Always confirm current availability with the study team.