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Preoperative or Postoperative Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel
Carboplatin
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To be included in this study, you must meet the following criteria: Non-small cell lung cancer Neoadjuvant candidates must have potentially resectable disease Adjuvant candidates must have had complete resection Clinical stage IB, II, or IIIA non-small cell lung cancer ECOG performance status 0 or 1 Adequate bone marrow, liver and kidney function No previous chemotherapy or radiation therapy for non-small cell lung cancer. Give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Stage IIIA with N2 nodes > 6 cm Stage IIIB or IV disease Age <18 years ECOG performance status 2 or higher Considered inoperable based on general medical condition History of prior malignancy within five years Women who are pregnant or lactating Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Overall response rates

    Secondary Outcome Measures

    Resectability rates
    Survival
    Time to progression
    Toxicity

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    March 17, 2015
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Bristol-Myers Squibb, Eli Lilly and Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193310
    Brief Title
    Preoperative or Postoperative Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer
    Official Title
    Preoperative (Neoadjuvant) or Postoperative (Adjuvant) Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2000 (undefined)
    Primary Completion Date
    November 2003 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Bristol-Myers Squibb, Eli Lilly and Company

    4. Oversight

    5. Study Description

    Brief Summary
    In this phase II study, we plan to evaluate several novel components of therapy. In patients with potentially resectable stages IIB (T3N0) and IIIA we will compare weekly paclitaxel and carboplatin with concomitant radiation therapy versus weekly paclitaxel and every 4 week carboplatin in the preoperative (neoadjuvant) setting. For patients with potentially resectable stage IB, IIA and IIB (T2N1) tumors, weekly paclitaxel and every 4 week carboplatin will be given pre-operatively (neoadjuvant). The feasibility of resection will be evaluated in the neoadjuvant group of patients. The continued study of concurrent radiation therapy with weekly paclitaxel and carboplatin will be evaluated in those patients with stage IIB (T3N0) and IIIA disease who initially had resection (adjuvant setting). Lastly, weekly paclitaxel and carboplatin every 4 weeks will be evaluated as an adjuvant program in patients who had completely resected stage IB, IIA and IIB (T2N1).
    Detailed Description
    Upon determination of eligibility, neo-adjuvant patients will be randomly assigned to one of two treatment arms: ARM A Paclitaxel + Carboplatin + Radiation Therapy + Surgery ARM B Paclitaxel + Carboplatin + Surgery After surgery neo-adjuvant patients with a complete resection will either receive Paclitaxel + Carboplatin or no therapy, depending on their stage of disease at time of enrollment. Patients with incomplete resection Paclitaxel + Carboplatin + Radiation Therapy. Adjuvant patients who enter the study after complete resection will receive Paclitaxel + Carboplatin with or without Radiation Therapy based on initial stage of disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    250 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Primary Outcome Measure Information:
    Title
    Overall response rates
    Secondary Outcome Measure Information:
    Title
    Resectability rates
    Title
    Survival
    Title
    Time to progression
    Title
    Toxicity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included in this study, you must meet the following criteria: Non-small cell lung cancer Neoadjuvant candidates must have potentially resectable disease Adjuvant candidates must have had complete resection Clinical stage IB, II, or IIIA non-small cell lung cancer ECOG performance status 0 or 1 Adequate bone marrow, liver and kidney function No previous chemotherapy or radiation therapy for non-small cell lung cancer. Give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Stage IIIA with N2 nodes > 6 cm Stage IIIB or IV disease Age <18 years ECOG performance status 2 or higher Considered inoperable based on general medical condition History of prior malignancy within five years Women who are pregnant or lactating Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony Greco, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Preoperative or Postoperative Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer

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