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

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rates

Principal Investigator

Anthony Greco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2000

Completion Date:

January 2009

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms