Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer
This research study is looking at an alternative way of delivering radiation therapy with protons. Protons are tiny particles with a positive charge that can be controlled to travel a certain distance and stop inside the body. In theory, this allows better control of where the radiation dose is delivered as compared to photons. Information from other research studies suggests that proton radiation may help to reduce unwanted side effects from radiation and allow an increase in radiation dose that increase the odds of tumor killing.
The purpose of this study is to determine the safest dose of proton radiation therapy to give in combination with standard chemotherapy in participants with Non-Small Cell Lung Cancer (NSCLC).
Non-Small Cell Lung Cancer
Radiation: Proton Beam Radiation
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Hypofractionated Proton Radiation Therapy With Cisplatin and Etoposide Followed by Surgery in Stage III Non-Small Cell Lung Cancer|
- MTD [ Time Frame: 1.5 years ] [ Designated as safety issue: Yes ]To establish the MTD of a proton beam-based regimen consisting of 25 fractions, together with concurrent standard cisplatin and etoposide chemotherapy followed by surgery +/- adjuvant chemotherapy for Stage III NSCLC, and to describe post-treatment surgical complications and treatment toxicity using CTCAE v4.0
- Downstaging and Response [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]To describe pathological downstaging and response following preoperative proton radiation and cisplatin/etoposide chemotherapy
- Biomarkers [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]To explore the predicitive value of biomarkers for radio- and chemosensitization in pre-treatment tumor biopsies and surgical specimens.
- Tumor Control and Survival Rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]To evaluate local and regional tumor control rates, progression free survival (PFS) rates, and overall survival rates and 2 and 5 years
|Study Start Date:||March 2012|
|Study Completion Date:||June 2015|
|Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Radiation, Chemotherapy and Surgery
Proton beam radiation, plus chemotherapy with cisplatin and etoposide, followed by surgery.
Radiation: Proton Beam Radiation
45-55 Gy total, 1.8-2.2 Gy x 25 fractions Mon-Fri for 5 weeksDrug: Cisplatin
50 mg/m2 IV on days 1, 8 of cycles 1 and 2Drug: Etoposide
50 mg/m2 IV on days 1-5 on Cycles 1-2
Proton radiation will be delivered daily Monday through Friday for 5 weeks. Study therapy will be give as an outpatient at the Francis H. Burr Proton Center at Massachusetts General Hospital.
During the weeks that subjects receive radiation, they will also receive 2 cycles of chemotherapy. Each cycle will last 28 days.
Cisplatin will be give as an IV infusion over 30-60 minutes or 1-2 hours on Days 1 and 8 of Cycles 1 and 2.
Etoposide will be given as an IV infusion over 60 minutes on Days 1, 2, 3, 4, 5 of Cycles 1 and 2.
After radiation and 2 cycles of chemotherapy are completed, subjects may have surgery to remove their tumor.
Following surgery, subjects may receive another 2 cycles of chemotherapy (Cycles 3 and 4). Each cycles lasts 21 days. Cisplatin is given on Day 1. Etoposide is given on Days 1, 2, and 3.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565772
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02214|
|Principal Investigator:||Henning Willers, MD||Massachusetts General Hospital|