Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer

A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Pre-operative chemotherapy; Other: Pre-operative concurrent chemoradiation therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jianxing He, MD, FACS; Phone Number: +86-20-83337792; Email: drjianxing.he@gmail.com
• Study Contact Backup: Name: Daoyuan Wang, MD; Phone Number: +86-20-83337792; Email: ghealth2008@gmail.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical College
      • Principal Investigator: Jianxing He, MD, FACS
      • Contact: Wenlong Shao, MD; Phone Number: 7040 +86-20-83337750; Email: myfriends2003@126.com
      • Contact: Daoyuan Wang, MD; Phone Number: 7040 +86-20-83337750; Email: ghealth2008@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-operative chemotherapy; Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)	Drug: Pre-operative chemotherapy; Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)
Active Comparator: Pre-operative concurrent chemoradiation therapy	Other: Pre-operative concurrent chemoradiation therapy; Chemotherapy: Docetaxel 20 mg/m2 + carboplatin area under the curve = 2 on D1 and 8, q3weeks, Pre-Op & Post-Op: 2 cycles (total 4 cycles). Concurrent thoracic radiotherapy: Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To estimate the time to recurrence	Every 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the pathologic complete response rate and the complete resection rate	Every 4 weeks
To estimate toxicities	Every 4 weeks

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Investigators: Principal Investigator: Jianxing He, MD, FACS, The First Affiliated Hospital of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: January 21, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Estimate): February 2, 2010
• Last Update Submitted That Met QC Criteria: February 1, 2010
• Last Verified: January 1, 2007

More Information

Terms related to this study

• Keywords: Neoadjuvant chemotherapy; neoadjuvant chemoradiotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: FAHG20070218