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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193310
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : March 18, 2015
Bristol-Myers Squibb
Eli Lilly and Company
Information provided by:
SCRI Development Innovations, LLC

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).

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: Paclitaxel Drug: Carboplatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative (Neoadjuvant) or Postoperative (Adjuvant) Therapy of Patients With Stages IB, II, IIIA Non-Small Cell Lung Cancer
Study Start Date : November 2000
Actual Primary Completion Date : November 2003
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Carboplatin
U.S. FDA Resources

Primary Outcome Measures :
  1. Overall response rates

Secondary Outcome Measures :
  1. Resectability rates
  2. Survival
  3. Time to progression
  4. Toxicity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193310

Sponsors and Collaborators
SCRI Development Innovations, LLC
Bristol-Myers Squibb
Eli Lilly and Company
Principal Investigator: Anthony Greco, MD SCRI Development Innovations, LLC Identifier: NCT00193310     History of Changes
Other Study ID Numbers: SCRI LUN 53
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents