Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer
In this research study the investigators are looking for the highest dose of a stereotactic radiation boost that can be given safely. Because stereotactic radiation is so precise, the investigators are testing whether it can be used to increase the dose to the primary tumor without significantly increasing the side effects the participant experiences; the goal is to improve the likelihood of killing the tumor.
Non-small Cell Lung Cancer
Radiation: Stereotactic radiotherapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer|
- Phase I: Maximally tolerated dose (MTD) of stereotactic boost radiotherapy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for stage II/III non-small cell lung cancer
- Phase II: Two-year local control rate following stereotactic boost radiotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]Local failure is defined as biopsy-proven recurrent disease, or if a biopsy is not attainable, by increasing fludeoxyglucose (FDG)-avidity on positron emission tomography-computed tomography (PET-CT) on 2 consecutive scans at least 1 month apart
- Risk of grade 2-3 radiation pneumonitis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]To evaluate the risk of radiation pneumonitis following stereotactic boost radiotherapy
- Overall survival rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the 2-year overall survival following stereotactic boost radiotherapy
- Disease-free survival rate [ Time Frame: 2 year ] [ Designated as safety issue: No ]To determine the 2-year disease-free survival
- Regional control rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]To determine the 2-year regional control rate.
- Change in pulmonary function [ Time Frame: 2 years ] [ Designated as safety issue: No ]To characterize the change in pulmonary function tests over the first 2 years after chemoradiotherapy
|Study Start Date:||December 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Radiation: Stereotactic radiotherapy
- Participants will undergo a radiation treatment simulation, or "mapping session" 7-14 days prior to starting radiation treatment. This is part of standard radiation treatment.
- Participants will start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment will be identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, participants will undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes will continue but the radiation treatment to the primary cancer site will stop until the last week (week 7). During week 7, participants will receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point.
- Participants will be seen by the radiation oncologist at least once every week during treatment.
- After the final dose of radiation treatment, all follow-up visits and tests are performed in accordance with standard cancer care. Participants will see the radiation oncologist, with or without the medical oncologist at the following time intervals: 1 week after treatment ends, 1 month after treatment ends, 2 months after treatment ends, and then every 3 months for two years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01222572
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Raymond H. Mak, MD||Dana-Farber Cancer Institute/Brigham and Women's Hospital|