NCT00096226

Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer

A Phase II Trial Of Neoadjuvant Therapy With Concurrent Chemotherapy And High Dose Radiotherapy Followed By Surgical Resection And Consolidative Therapy For Locally Advanced Non-Small Cell Lung Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving paclitaxel and carboplatin together with radiation therapy before surgery may shrink the tumor so that it can be removed. Giving chemotherapy after surgery may kill any tumor cells remaining after surgery. PURPOSE: This phase II trial is studying how well giving paclitaxel and carboplatin together with radiation therapy works in treating patients who are undergoing surgery for stage III non-small cell lung cancer.

Detailed description

OBJECTIVES: * Determine the mediastinal node clearance rate in patients with stage IIIA or IIIB non-small cell lung cancer treated with neoadjuvant induction chemoradiotherapy comprising paclitaxel, carboplatin, and high-dose radiotherapy followed by surgical resection for patients found to be resectable and consolidative chemotherapy comprising paclitaxel and carboplatin. * Determine the rate of complete pathological response in patients treated with this regimen. * Determine the feasibility of surgical resection after neoadjuvant induction chemoradiotherapy in these patients. * Determine disease-free and overall survival of patients treated with this regimen. * Determine the toxicity of this regimen in these patients.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Induction Carboplatin
DRUG	Induction Paclitaxel
PROCEDURE	Resection
DRUG	Consolidation Carboplatin
RADIATION	Radiation Therapy
DRUG	Consolidation Paclitaxel

Timeline

• Start date: 2004-09-01
• Primary completion: 2012-04-01
• Completion: 2016-05-16
• First posted: 2004-11-09
• Last updated: 2019-09-18
• Results posted: 2014-02-27

Locations

22 sites across 1 country: United States