Phase I Dose Escalation Trial of Proton Beam Radiotherapy With Concurrent Chemotherapy and Nelfinavir for Inoperable Stage III NSCLC
1. Determine MTD of proton beam radiotherapy with concurrent cisplatin and etoposide for
stage III NSCLC.
2. Determine MTD of proton beam radiotherapy with concurrent carboplatin and paclitaxel
for stage III NSCLC in non-cisplatin candidates.
3. Determine MTD of Nelfinavir with concurrent chemoradiotherapy for stage III NSCLC at
RPTD of proton beam radiotherapy.
4. Develop biomarker for clinical outcome with concurrent chemoradiotherapy in stage III
5. To determine clinical efficacy, as defined by metabolic response, sites of recurrence
(e.g., local, regional, distant) and progression-free and overall survival.
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
Feasibility will be based on multiple radiation planning and treatment parameters.Treatment will be deemed infeasible if patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised. Patient is unable to tolerate 30% of treatments using proton radiotherapy, that is, up to 70% of treatments could be delivered using photons. Patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion or require a treatment break greater than 5 days.
10 days of estimated date of treatment completion or requires a treatment break greater than 5 days
United States: Institutional Review Board
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|