Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer

Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:Any
Start Date:December 2010
Contact:David J. Sher, MD, MPH

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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.

- Participants will undergo a radiation treatment simulation, or "mapping session" 7-14
days prior to starting radiation treatment. This is part of standard radiation

- 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

- 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.

Inclusion Criteria:

- Histologically or cytologically confirmed stage II or stage III non-small cell lung
cancer, or stage IV non-small cell lung cancer that will be treated with curative

- Evaluated by a surgeon and deemed inoperable

- Measurable disease, defined as at least one lesion that can be accurately measured in
at least one dimension as 10mm or greater with chest CT scan.

- No active malignancy within the past 5 years, except for non-melanoma skin cancers or
carcinoma in situ of the cervix

- 18 years or older

- Life expectancy of greater then 6 months

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

- Normal organ and marrow function as outlined in the protocol

- Forced expiratory volume (FEV1) of 1 L or greater OR 50% or greater of predicted

Exclusion Criteria:

- Primary tumor size greater then 6cm

- Prior history of thoracic radiotherapy

- May not be receiving any other study agents

- History of pulmonary fibrosis

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to cisplatin or etoposide

- Primary tumor < 1.5 cm beyond hilar lymphadenopathy (if any) and 1.5 cm from proximal
bronchial tree, defined as the trachea, right and left mainstem bronchus, and lobar
bronchi until the 1st lobar segment

- Uncontrolled intercurrent illness including but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant or breast feeding women

- Individuals with a history of a different malignancy are ineligible except for the
following circumstances. Individuals with a history of other malignancies are
eligible if they have been disease-free for at least 5 years and are deemed by the
investigator to be at low risk for recurrence of that malignancy. Individuals with
the following cancers are eligible if diagnosed and treated within the past 5 years:
cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin

- Human immunodeficiency virus (HIV)-positive individuals on combination antiretroviral

- Patients who are planned to receive the following medication: granulocyte
colony-stimulating factor (G-CSF), bevacizumab, cetuximab, cyclosporine, anti-tumor
necrosis factor agents, amifostine.
We found this trial at
450 Brookline Ave
Boston, Massachusetts 2215
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
Boston, MA
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