Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer

This research study is a Phase I clinical trial, which tests the safety of an investigational
intervention and also tries to define the appropriate dose of the investigational
intervention to use for further studies. "Investigational" means that the intervention is
being studied.

The U.S. Food and Drug Administration (FDA) has approved radiation with chemotherapy as a
treatment option for your disease.

Currently, there are no established rules to avoid esophagitis in the treatment of lung
cancer with radiation therapy. We have developed an IMRT-based technique, termed CEST, to
reduce the radiation dose to the part of the esophagus that is located opposite to the tumor.
The reason behind this approach is that a lower radiation dose causes less esophagus
inflammation and irritation and, therefore, may preserve the swallowing function of the
esophagus better. In our clinical experience, reducing the radiation dose to part of the
esophagus in this fashion has shown the potential to dramatically decrease the likelihood of
severe esophagitis in many though not all people with lung cancer. We therefore wish to
analyze this technique further.

There is no firm data to indicate that different chemotherapy regimens given at the same time
of radiation therapy result in different rates of esophagitis. The Investigators will,
therefore, allow any type of standard-of-care chemotherapy regimen at the discretion of the
patient's medical oncologist.

Inclusion Criteria:

Participants must meet the following criteria on screening examination to be eligible to
participate in the study.

- Histologically or cytologically proven diagnosis of NSCLC or SCLC

- NSCLC, patients with clinical stage IIB-IV patients (AJCC, 7th ed.) are eligible, and
for SCLC, limited-stage patients are eligible, if documented to be a candidate for
definitive radiation and concurrent chemotherapy in the radiation oncologist or
medical oncologist clinic note.

- Stage IV NSCLC patients are eligible only if they have a solitary brain
metastasis

- Patients with non-malignant pleural effusion are eligible. --- If a pleural
effusion is present, the following criteria must be met to exclude malignant
involvement:

- When pleural fluid is visible on both the CT scan and on a chest x-ray, a
pleuracentesis is required to confirm that the pleural fluid is
cytologically negative.

- Exudative pleural effusions are excluded, regardless of cytology;

- Effusions that are minimal (ie, not visible on chest x-ray) that are too
small to safely tap are eligible.

- Gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus on
the most recent chest CT scan.

- ECOG performance status 0-1 within 30 days prior to registration;

- Age ≥18

- Women of childbearing potential must indicate that there is not a possibility of being
pregnant at the time of enrollment or have a negative serum pregnancy test prior to
the initiation of radiation therapy.

- Women of childbearing potential and male participants must practice adequate
contraception.

- Patient must provide study-specific informed consent prior to study entry.

Exclusion Criteria:

Participants who exhibit any of the following conditions at screening will not be eligible
for admission into the study.

- Greater than minimal, exudative, or cytologically positive pleural effusions

- Tumor suspected or known to invade the esophagus

- Prior chemotherapy if this precludes administration of concurrent chemotherapy for
protocol treatment. Note that induction chemotherapy is allowed as long as concurrent
chemotherapy is possible.

- Prior radiotherapy to the region of the study cancer that would result in overlap of
radiation therapy fields

- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note,
however, that HIV testing is not required for entry into this protocol. The need to
exclude patients with AIDS from this protocol is necessary because the treatments
involved in this protocol may be significantly immunosuppressive. Protocol-specific
requirements may also exclude immuno-compromised patients.

- Pregnancy or women of childbearing potential and men who are sexually active and not
willing/able to use medically acceptable forms of contraception; this exclusion is
necessary because the treatment involved in this study may be significantly
teratogenic.

- Any history of allergic reaction to chemotherapies used