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0516 GCC: Stereotactic Body Radiation Therapy As A Boost After Definitive Treatment With Concurrent Chemoradiation In Patients With Non-Small Cell Lung Cancer

Phase 1
18 Years
Not Enrolling
Non-Small Cell Lung Cancer (NSCLC)

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Trial Information

0516 GCC: Stereotactic Body Radiation Therapy As A Boost After Definitive Treatment With Concurrent Chemoradiation In Patients With Non-Small Cell Lung Cancer

This protocol is designed to use stereotactic body radiation therapy (SBRT) to deliver a
boost dose to residual primary tumor after definitive doses of standard external beam
radiation have been delivered concurrently with chemotherapy. It is designed to determine
the toxicity profile(side effects) in the context of dose escalation of stereotactic body
radiation therapy (SBRT) after definitive therapy with concurrent chemoradiation and to
define the maximum tolerated dose.

Serum levels of TGF-Beta1 have been demonstrated to correlate with the incidence of the
radiation toxicity, pneumonitis in patients treated with standard external beam radiation.
This study will serially follow TGF-Beta1 levels in patients to see if the same correlation
exists with SBRT toxicity.

Inclusion Criteria:

1. Histological confirmation of non-small cell lung cancer will be required by either
biopsy or cytology. The following primary cancer types are eligible: squamous cell
carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar cell carcinoma,
or non-small cell carcinoma not otherwise specified.

2. Eligible patients must have appropriate staging studies identifying them as specific
subsets of AJCC stage III based on only one of the following combinations of TNM

- T1N2-3M0

- T2N2-3M0

- T3N1-3M0

- Patients with T4 tumors (by any definition) are not eligible

3. Patients must have completed treatment with concurrent chemotherapy and external beam
radiation therapy to radiation doses >59.4Gy but <70.2Gy to the primary tumor and
doses >45Gy but <70.2Gy to mediastinal structures within 6 to 9 weeks of the first
SBRT "Boost" treatment.

4. Patients must have had repeat staging performed after their chemoradiation and within
28 days of their first protocol treatment including: CT scan of chest and upper
abdomen, FDG-18 PET scan and MRI of the brain. These studies must demonstrate no
disease outside of the thorax.

5. The primary tumor must be deemed technically resectable after chemoradiation by an
experienced thoracic cancer clinician, with a reasonable possibility of obtaining a
gross total resection with negative margins (defined as a potentially curative
resection, PCR). However, the patient must not be a candidate for PCR based on
pathologic evidence of persistent mediastinal lymphadenopathy after chemoradiation or
because of underlying physiological medical problems that would prohibit a PCR due to
a low probability of tolerating general anesthesia, the operation, the postoperative
recovery period, or the removal of adjacent functioning lung. These types of patients
with severe underlying health problems are deemed "medically inoperable." Standard
justification for deeming a patient medically inoperable based on pulmonary function
for surgical resection of NSCLC may include any of the following: Baseline FEV1 < 40%
predicted, post-operative predicted FEV1 < 30% predicted, severely reduced diffusion
capacity, baseline hypoxemia and/or hypercapnia, exercise oxygen consumption < 50%
predicted, severe pulmonary hypertension, diabetes mellitus with severe end organ
damage, severe cerebral, cardiac, or peripheral vascular disease, or severe chronic
heart disease.

6. Patients must be ≥ 18 years of age.

7. The patient's Zubrod performance status must be Zubrod 0-2.

8. Women of childbearing potential and male participants must use an effective
contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine
device (IUD), or prescription birth control pills.

9. Pretreatment Evaluations Required for Eligibility include:

- A medical history, physical examination, weight, assessment of Zubrod
performance status within 2 weeks prior to study entry.

- Evaluation by a thoracic surgeon or pulmonologist within 4 weeks prior to study

- For women of childbearing potential, a serum or urine pregnancy test must be
performed within 72 hours prior to the start of protocol treatment;

- PFTs: Routine spirometry, lung volumes, diffusion capacity, and arterial blood
gases within 4 weeks prior to study entry.

Mandatory staging studies: Must be done within 21 days prior to study entry

- CT scan (preferably with intravenous contrast) to include the entirety of both
lungs, the mediastinum, liver, and adrenal glands; Primary tumor dimension will
be measured on CT.

- Whole body positron emission tomography (PET) scan using FDG with adequate
visualization of the primary tumor and draining lymph node basins in the hilar
and mediastinal regions.

- MRI of the brain

10. Patients must sign a study-specific consent form.

11. Patients must not have any serious medical or psychiatric illnesses that would
prevent compliance or ability to give informed consent.

12. Labs to be within 14 days of start of SBRT:

CBC with differential, platelet count, Comprehensive metabolic panel including:
electrolytes, Albumin, TBilirubin, Calcium, Cl, CO2, Creatinine, Glucose, K, TProtein, Na,
BUN, AlkPhos, AST, ALT, Magnesium.

Pre-treatment laboratory values must be as follows:

WBC count: < or = 2.5 x institutional ULN; Absolute granulocyte count: > or = 1,500/mm3
Platelets: > or = 100,000/mm3 Total bilirubin: < or = 1.5 x institutional ULN Serum
creatinine: < or = 1.5x institutional ULN AST and ALT: < or = 2.5 x institutional ULN
Serum albumin: > or = 3.0 g/dL

Exclusion Criteria:

1 Patients with primary tumors > 5 cm or involving the central chest and structures of the
mediastinum after their definitive course of chemoradiation.

2. The primary tumor of any T-stage within or touching the zone of the proximal bronchial
tree defined as a volume 2 cm in all directions around the proximal bronchial tree
(carina, right and left main bronchi, right and left upper lobe bronchi, intermedius
bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe

- Patients with radiographic pneumonitis obscuring clear delineation of the primary
tumor or any patient who developed clinical radiation pneumonitis from their course
of chemoradiation prior to protocol treatment.

- Direct evidence of regional or distant metastases after appropriate staging studies.

- Plans for the patient to receive other concomitant antineoplastic therapy (including
standard fractionated radiotherapy, chemotherapy, biological therapy, vaccine
therapy, and surgery). Patients may receive antineoplastic therapy at the discretion
of their treating physician beginning 6 weeks after completion of protocol therapy.

- Patients with active systemic, pulmonary, or pericardial infection.

- Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo
or fetus.

- Major illness or psychiatric impairments, which in the investigator's opinion will
prevent administration or completion of the protocol therapy and /or interfere with

Type of Study:


Study Design:

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

Outcome Measure:

To determine the toxicity profile in the context of dose escalation of stereotactic body radiation therapy (SBRT) after definitive therapy with concurrent chemoradiation and to define the maximum tolerated dose.

Outcome Time Frame:

Follow-up Post-SBRT: 2, 4, 6,12 weeks, every 3 months for 2 years, every 6 months for 2 years, then at the discretion of the treating M.D.

Safety Issue:


Principal Investigator

Anil Dhople, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland, Baltimore County


United States: Institutional Review Board

Study ID:




Start Date:

January 2009

Completion Date:

October 2009

Related Keywords:

  • Non-Small Cell Lung Cancer (NSCLC)
  • IIIA, selected IIIB
  • (T1N2-3M0, T2N2-3M0, T3N1-3M0)
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms