Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC
This is a phase II study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage IIIA and IIIB non-small cell lung cancer
Checked against the public recordLast updated Mar 14, 2018 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Leo W. Jenkins Cancer Center
- Interventions being studied
- Drug: Taxol (paclitaxel); Procedure: Radiotherapy; Drug: Carboplatin; Drug: Gemcitabine
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion. 2. Patients will be included in the study based on the following criteria: * Patients must be older than 18 years old. * Patients must have a Zubrod performance status of 0 to 2 * Patients with adequate bone marrow function * Patients with adequate renal function * Patients with adequate hepatic function * Patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception. * Patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation. * Patients who have signed an approved informed consent and authorization permitting release of personal health information. Exclusion Criteria: 1. Disease-Specific Exclusions * Superior sulcus tumors * Atelectasis or obstructive pneumonitis of the entire lung * Malignant pleural effusion 2. General Medical Exclusions * Surgical candidates * Patients who are pregnant at the time of diagnosis * Serious concomitant systemic disorders incompatible with the study * Inability to comply with study and/or follow-up procedures * Life expectancy of less than 12 weeks * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study * Patients with septicemia or severe infection. * Patients who have circumstances that will not permit completion of this study or the required follow-up * Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Brody School of Medicine at East Carolina UniversityGreenville, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 14, 2018. Always confirm current availability with the study team.