Status:
TERMINATED
Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC
Lead Sponsor:
Leo W. Jenkins Cancer Center
Conditions:
Lung Neoplasms, Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 intr...
Detailed Description
Patients with histological documented non-small cell lung cancer, that are considered to be inoperable, meet all the eligibility criteria, and sign informed consent will be treated with one cycle of i...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2017
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02275806
Start Date
October 1 2014
End Date
September 27 2017
Last Update
August 21 2019
Active Locations (1)
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1
Leo W Jenkins Cancer Center
Greenville, North Carolina, United States, 27834