NCT01416961

Integration of Neutron Therapy in the Treatment Plan for Stage III Non-Small Cell Lung Cancer (NSCLC)

Phase I Study of High Linear Energy Transfer (Neutron) Therapy Followed by Concurrent Chemotherapy and Standard Photon Thoracic RT (TRT) in Stage III NSCLC (Non-Small Cell Lung Cancer) Patients

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	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.
DRUG	Chemotherapy - Squamous Cell Histologies	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
DRUG	Chemotherapy - NSCLC other than squamous cell	Cisplatin 75 mg/m2 days 1,22,43; Pemetrexed 500 mg/m2 days 1,22,43

Timeline

• Start date: 2011-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-08-15
• Last updated: 2012-08-22