Lung Neoplasms, Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase II Study of Definitive Concurrent Radiation Therapy With Cisplatin and Irinotecan Chemotherapy in Locally Advanced In-operable Non-Small Cell Lung Cancer
Verified date | October 2018 |
Source | Leo W. Jenkins Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Terminated |
Enrollment | 4 |
Est. completion date | September 27, 2017 |
Est. primary completion date | September 27, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Leo W Jenkins Cancer Center | Greenville | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Leo W. Jenkins Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Estimate the median and three year survival rate of locally advanced NSCLC using the platinum doublet cisplatin and irinotecan | Three years after the last patient has completed treatement | ||
Primary | Estimate the progression-free survival | Three years after the last patient has completed treatement. | ||
Secondary | Compare the survival of patients treated with cisplatin/irinotecan with historical controls using cisplatin/etoposide. | Three years after the last patient has completed treatment. | ||
Secondary | Measure toxicities and compliance of patients on this regimen | Thirty days after completing treatment, averaging 100 days. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer
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N/A |