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Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Non-small Cell Lung Cancer, Lung Cancer, NSCLC

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Trial Information

Stereotactic Boost for Locally Advanced Non-Small Cell Lung Cancer

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase I: Maximally tolerated dose (MTD) of stereotactic boost radiotherapy

Outcome Description:

Determination of the MTD and dose-limiting toxicities of a stereotactic boost to chemoradiotherapy for stage II/III non-small cell lung cancer

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Raymond H. Mak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute/Brigham and Women's Hospital


United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

October 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • radiation therapy
  • stereotactic radiotherapy
  • stereotactic boost
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115