Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedTaxol (paclitaxel) and Radiotherapy

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 14, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Leo W. Jenkins Cancer Center

Study sponsor

Study overview

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

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Locally advanced→

Treatment approach

Chemotherapy→Radiation therapy→

Study topics

After surgery (adjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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