Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC

Stopped early · Phase 2

Conditions studied: Lung Neoplasms, Non-Small Cell Lung Cancer

In brief

This is a prospective, single institution phase II study, whose primary objective is to estimate the median and three year survival rate of non-small lung cancer patients with Stage IIIA and IIIB intra-thoracic disease which is referred to as "locally advanced" non-small cell lung cancer (NSCLC).

Key facts

Study ID

NCT02275806

Run by

Leo W. Jenkins Cancer Center

People needed

4

Starts

2014-10-01

Expected to finish

2017-09-27

Last updated by the study team

2019-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological documented NSCLC, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma adenosquamous and sarcomatoid carcinomas.
• Patients with Pancoast tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. Pancoast tumor patients will be so-noted in the registry.
• Patients must be ≥ 18 years of age.
• Patients with Zubrod (ECOG) performance status ≤ 2.
• Adequate hematologic function defined as: 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.
• 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 and for four weeks after completion of treatment.
• Pretreatment evaluations required for eligibility include:
• A medical history, physical examination, and assessment of Zubrod performance status within 4 weeks prior to study entry.
• CBC with differential and platelet count, and laboratory profile must be completed within 4 weeks prior to study entry.
• 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 (minimum sensitivity 25 IU/L or equivalent units of HCG) must be performed 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.

You may not qualify if…

• Small cell carcinomas or carcinoid histology.
• History of any 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.
• Prior systemic chemotherapy or radiotherapy that would interfere with delivery of treatment as outlined above as judged by the clinician.
• Cytologically malignant effusions.
• Radiographic evidence of metastatic disease.
• Active pulmonary infection not responsive to antimicrobial therapy.
• History of significant or symptomatic interstitial pneumonitis.
• Significant symptomatic cardiac disease, for example, unstable angina, uncompensated congestive heart failure, or uncontrolled cardiac ventricular arrhythmias.
• Patients with > grade 2 neuropathy.
• Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant; women with a positive pregnancy test on enrollment or prior to study drug administration.
• Women of childbearing potential who are unwilling to practice effective contraception throughout the study and for four weeks after completion of treatment.
• Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials in the previous 30 days.

Where it is running

• Leo W Jenkins Cancer Center — Greenville, North Carolina, United States

Full record on ClinicalTrials.gov

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