This study is needed to assess the feasibility of integrating this therapy with current treatment regimens. If this study shows success a formal phase II test study to conduct feasibility will be the next step. The first dose level chosen for this study is 66Gy of radiation to the tumor between LET and standard photon therapy. This dose is the current standard of care for stage III . If this dose is found to be feasible then the dose of LET will escalate to the total dose of 74Gy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Concurrent chemo and photon radiation therapy will start within 7 days of completing neutron therapy. There will be a Day 1 of neutron therapy and a Day 1 of concurrent therapy.Photon radiation therapy will begin within 24 hours of the first cycle of chemotherapy and will be delivered 5 days per week, one fraction per day, in 1.8 Gy per fraction. High LET radiotherapy will be delivered in 1 NGy per fraction five days per week. High LET radiotherapy will be delivered first followed by combined chemoradiotherapy.
Cisplatin 50 mg/m2 administered on days 1,8, 29, 36; Etoposide 50 mg/m2 administered on days 1-5 and then again days 29-33
Assess Dose levels (DLT & MTD)integrating 2 dose levels of neutron tx in 2 diff regimens of approx 12 pts/trt; If 1st dose level feasible but not 2nd dose level in either cohorts then 12 pts will be trted at 1st dose level for that particular cohort
Lab value chgs (CBC w/diff, electrolytes, serum cr., calc. cr. clearance, bilirubin, AST, ALT, ca, mg, LDH, albumin)\& for AE's-wks. 2, 5, 6, 8 \& 1 mth. after therapy. Dose Limiting Toxicities (DLT): Gr 3/4 non-hematologic tox that is trtment related; Gr 4 thrombocytopenia, Gr 3/4 neutropenic fever or gr 4 neutropenia lasting \> 7 days. Assess 2 dose levels, the maximum tolerated dose (MTD) of neutron therapy-dose at which \< 33% of the pts. experience DLT.
Time frame: up to one month after therapy
To assess the Progression Free Survival (PFS), and response rate in these patients.
Time frame: CT scan of the chest to assess the status of the cancer within 30 days of completion of therapy. If the patient has had complete or partial response, then a repeat scan no sooner than 4 weeks should be done to confirm the response.
To assess the expression of p16 expression, ERCC1 and TS expression in tumors of enrolled patients and assess the correlation of these markers with response rate and progression free survival.
Time frame: Archival tissue samples collected at baseline will be assessed at baseline & 1 month after therapy
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Cisplatin 75 mg/m2 days 1,22,43; Pemetrexed 500 mg/m2 days 1,22,43