Summary

This clinical trial tests proton beam radiation therapy in patients after treatment for N2 non-small cell lung cancer that has been removed by surgery (resected). Proton therapy is a kind of radiation used to treat cancer. Like other types of radiation, proton therapy kills cancer cells and stops them from growing. Proton beam therapy is sometimes used after cancer surgery to reduce the risk of cancer recurrence (coming back). Giving proton beam radiation therapy may work better after surgery in patients with resected non-small cell lung cancer compared to conventional radiation treatment.

Objectives

PRIMARY OBJECTIVE:
I. To assess the safety of proton beam radiation therapy (PBRT) for resected N2 non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:
I. To measure the radiation dose to the circulating immune compartment and explore its association with clinical endpoints.
II. To assess the efficacy of PBRT for resected N2 NSCLC.

OUTLINE:
Patients undergo radiation treatment planning and then undergo proton beam radiation therapy, over 27-30 treatments, in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the study and computed tomography (CT) or positron emission tomography (PET)/CT during follow-up.

Patients are followed up for 24 months after first dose of radiotherapy.

Eligibility

1. Age >= 18 years
2. Patients must have undergone complete surgical resection after pre-operative systemic therapy. Complete resections are defined as BOTH lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy AND lymph node dissection with at least three mediastinal (N2) stations sampled
3. Pathology report from surgical resection indicating complete resection of primary tumor (R0 resection) AND tumor involvement of at least one mediastinal lymph node (pN2) AND no tumor involvement of highest dissected mediastinal lymph node. Patients who have initially positive margins that are secondarily cleared on additional margins will be eligible
4. Eastern Cooperative Oncology Group Performance (ECOG) performance status =< 2 (Karnofsky >= 60%)
5. Life expectancy > 12 weeks as determined by the investigator
6. Hemoglobin >= 9.0 g/dl (no transfusions allowed within 7 days of simulation to meet entry criteria) (within 28 days of cycle 1 day 1)
7. White blood cell >= 2000/uL (after at least 7 days without growth factor support or transfusion) (within 28 days of cycle 1 day 1)
8. Platelets >= 100,000/mcL (no transfusions allowed within 7 days of cycle 1 day 1 to meet entry criteria) (within 28 days of cycle 1 day 1)
9. Serum creatinine =< 2 mg/dL (or glomerular filtration rate >= 40 mL/min) (within 28 days of cycle 1 day 1)
10. Because radiotherapy is known to be teratogenic, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
11. FCBP and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of radiotherapy. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
12. Completion of all previous therapy (including surgery, chemotherapy, or investigational therapy) for the treatment of cancer >= 2 weeks before the start of radiotherapy
13. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
14. Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions
15. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation

Treatment Sites in Georgia