Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Pre-operative chemotherapy Type: Drug
Name: Pre-operative concurrent chemoradiation therapy Type: Other
Overall Status
Recruiting
Summary
This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.
Detailed Description
Management of locally advanced non-small cell lung cancer (NSCLC) remains a challenge. Both local relapses and distant metastases are frequent, with 5-year survival of 3-17% for inoperable disease. Staging has historically subdivided stage III disease into clinical stage IIIA, thought to be potentially amenable to surgery, and stage IIIB, treated by defi nitive radiotherapy or radiochemotherapy. This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced NSCLC to address optimal induction strategy.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 85 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histopathologic diagnosis of non small-cell lung cancer

- Clinical stage IIIA and/or IIIB without pleural effusion

- ECOG functional status 0 or 1

- No renal function alteration (GFR >50%)

- No hepatic function alteration (ALT and AST less than 2 times its normal value)

- Leucocytes more than 2,000/mcl

- Hemoglobin more than 10mg/dL

- Platelets more than 100,000/mcl

Exclusion Criteria:

- Active uncontrolled infection.

- Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.

- MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.

- Significant neurological or mental disorder.

- Second primary malignancy.

- Pregnant or nursing.
Location
The First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Wenlong Shao, MD - +86-20-83337750 - myfriends2003@126.com
Start Date
February 2007
Completion Date
December 2011
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Source
The First Affiliated Hospital of Guangzhou Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page