Observation Study of Patients With Non-Small Cell Lung Cancer and Esophageal Cancer Treated With Chemo-Radiation Followed by Surgery

Patients who are eligible for the phase I trial (RT-101) but decline to enroll should be offered to participate in this parallel observation study. Patients with the following disease will be included in this observation study:

I. non-small cell lung cancer, Stage IIIA (T1-3 N2 M0) II. localized esophageal cancer, ≥T2, or N+, and M0

Patients on this observation study must have planned treatment regimen with concurrent CRT followed by planned surgery, which is considered as standard of care for their disease.

Inclusion Criteria:

1. Patient must have pathologically-confirmed and previously untreated:

   • Non-small cell lung cancer, Stage IIIA (T1-3 N2 M0); OR
   • Localized esophageal cancer, ≥T2, or N+, and M0 according to the American Joint Committee on Cancer (AJCC) 7th edition staging.
2. The planned treatment regimen must be concurrent chemoradiation with Carboplatin-Paclitaxel followed by surgery.
3. Age > 18 years.
4. ECOG performance status is 0-1.

5. Laboratory studies must meet each of the following criteria (with labs drawn within 4 weeks prior to the registration):

   • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
   • Platelets ≥100,000 cells/mm3
   • Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable)
   • Creatinine ≤2 X the upper limit of normal
   • Bilirubin ≤ 1.5 X upper limit of normal
   • AST ≤ 3 X upper limit of normal
6. Men and women of childbearing potential must be willing to exercise an effective form of birth control (abstinence/contraception) while on study and for 3 months after therapy completed.
7. Patients must be able to read and write English to comply with the questionnaire portions of the protocol.
8. Subjects must sign a written informed study consent and HIPAA consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.

Exclusion Criteria:

1. Patients who have had previous radiotherapy in the thorax.
2. Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity.
3. Patients who have a history scleroderma or other active connective tissue disease.

9 Women of childbearing potential must not be pregnant and non-lactating. They are required to have a negative serum pregnancy test within 72 hours prior to registration or they can decline the pregnancy test with the specific supporting reason such as not sexually active or using birth control; postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential; woman status post oophorectomy or hysterectomy are considered non-childbearing potential.

4 Patients who have uncontrolled inter-current illness including, but not limited to, psychiatric illness/social situations that would limit compliance with study requirements.