Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02054819 : Treating NSCLC Minimal Stage IV With Curative Intent
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Histological or cytological documented NSCLC, including squamous cell carcinoma,
adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma
and poorly differentiated (not otherwise specified — NOS) non-small cell lung cancer.
Bronchial alveolar adenocarcinoma and totally resected tumors are excluded. All
histology is to be reviewed at East Carolina University or designated participating
center.

- Patients with Stage II-IIIB intra-thoracic disease with oligometastatic disease
(hereafter referred to as "Stage IVa" disease) are eligible. Definition of Stage IVa:

Metastatic disease; either biopsy proven or with strong radiographic evidence suggesting
its existence.

As determined by CT, MRI or PET no more than five distinct metastatic sites. All
metastatic disease must be anatomically located in such a way as to permit a reasonable
attempt at permanent ablation. Ablative measures may include surgery, stereotactic
radiosurgery, and external beam therapy. Patients who meet the minimal metastatic disease
requirement and who would otherwise have been staged II, IIIA or IIIB.

- Patients with tumors adjacent to a vertebral body are eligible as long as all gross
disease can be encompassed in the radiation boost field.

- Patients must be ? 18 years of age.

- Patients with Zubrod (ECOG) performance status ? 2.

- Adequate hematologic function defined as: absolute neutrophil count (ANC) ? 1000/mm3,
platelets ? 75,000/mm3, and hemoglobin ? 8 g/dL (prior to transfusions); adequate
hepatic function defined as: total bilirubin ? 3.0 mg/dl, and adequate renal function
defined as a serum creatinine level ? 2.0 mg/dl.

- Forced expiratory volume (FEV1) ? 800ml.

- Patients with weight loss < 20% over the past 3 months.

- Patients with a pleural effusion that is proven cytologically negative or is too
small to tap.

- Women of childbearing potential must agree to practice effective contraception
throughout the study plus four weeks.

- Pretreatment evaluations required for eligibility include:

A medical history, physical exam, and Zubrod performance status within 3 weeks prior to
study entry.

Complete blodd count (CBC) with differential and platelet count, and laboratory profile
must be completed within 3 weeks prior to study entry.

FEV1, CT scan of the chest or whole body PET (preferred), and a CT scan or MRI (preferred)
of the brain within 4 weeks prior to study entry.

For women of childbearing potential, a serum or urine pregnancy test within a week prior
to the start of protocol treatment.

Medical Oncology and Radiation Oncology consultation and approval.

- Patients must sign a study-specific consent form prior to study entry.

Exclusion Criteria:

- Prior systemic chemotherapy or radiotherapy that would interfere with delivery of
treatment as outlined above as judged by the clinician.

- Cytologically malignant effusions.

- Metastatic disease beyond what is described in section 3.1.2.

- Active pulmonary infection not responsive to antimicrobial therapy.

- History of symptomatic interstitial pneumonitis.

- Significant symptomatic cardiac disease, i.e., unstable angina, uncompensated
congestive heart failure, or uncontrolled cardiac ventricular arrhythmias.

- Patients with > grade 2 neuropathy.

- Evidence of malignancy in the past 2 years except for adequately treated basal cell
or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers.

- Women who are pregnant or breast feeding.

- Women of childbearing potential who are unwilling to practice effective
contraception.

- Patients who currently are participating in other clinical trials and/or who have
participated in other clinical trials in the previous 30 days.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02054819      |      Link to official Clinicaltrials.gov listing
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