Status:
WITHDRAWN
Personalized Adaptive Radiation Therapy With Individualized Systemic Targeted Therapy (PARTIST) for Locally Advanced, Non-small Cell Lung Cancer With Genomic Driver Mutations
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Augusta University
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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, E...
Detailed Description
The proposed trial is a pilot study that will accrue 30 patients with inoperable stage IIIA/B NSCLC harboring either an EGFR mutation (n=20) or an ALK rearrangement (n=10). Patients with EGFR+ tumors ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02277457
Start Date
September 1 2015
Last Update
June 24 2016
Active Locations (1)
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1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48187