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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: Carboplatin

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193310

SCRI LUN 53

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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.